tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Great American Marketing Company
MARCS-CMS 539865 —
January 28, 2020
Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Bill D. Welch
Recipient Title
President
Great American Marketing Company
1224 North Post Oak Road
Houston
,
TX
77055
United States
Issuing Office:
Office of Human and Animal Food-West Div. 3
United States
214-253-5200
Dear Mr. Welch:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (CMS Case 539865) issued on February 16, 2018. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Casey Hamblin
Recall Coordinator/Compliance Officer
Office of Human and Animal Food-West Div. 3
Content current as of:
02/03/2020
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Harold Brey & Sons Inc.
MARCS-CMS 585292 —
April 02, 2020
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Daniel Brey & Ms. Nancy Brey
Recipient Title
Co-Owners
Harold Brey & Sons Inc.
607 Swiss Hill Rd.
Jeffersonville
,
NY
12748
United States
Issuing Office:
Office of Human and Animal Food Operations East Division 1
United States
Dear Mr. & Ms. Brey:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 585292, issued on September 24, 2019. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Scott M. Loughan
Acting Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
04/10/2020
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Health-Chem Acquisitions, LLC
MARCS-CMS 526232 —
June 24, 2020
Delivery Method:
Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Jack Aronowitz
Health-Chem Acquisitions, LLC
3341 SW 15th Street
Pompano Beach
,
FL
33069
United States
jaronowitz@healthchemdiagnostics.com
Issuing Office:
Office of Medical Device and Radiological Health Operations Division 2 Central
United States
(407) 475-4700
Dear Mr. Aronowitz:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter dated December 7, 2017. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Blake Bevill, MS
Program Division Director
Division 2/Central, OMDRHO
Content current as of:
06/29/2020
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Herbal Amy Inc.
MARCS-CMS 604813 —
July 08, 2020
Product:
Food & Beverages
Recipient:
Recipient Name
Amy Weidner
Herbal Amy Inc.
12575 Anakate Ln.
Nampa
,
ID
83686
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Amy Weidner,
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our COVID-19 Warning Letter Re: 604813, issued March 06, 2020. Based on our evaluation, it appears you have addressed the violation(s) contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Carrie Lawlor
Branch Chief
Dietary Supplement and Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
07/15/2020
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Herbal Healer Academy, Inc.
MARCS-CMS 570957 —
May 11, 2020
Delivery Method:
UPS Overnight
Product:
Dietary Supplements
Recipient:
Recipient Name
Misty D. Huff
Herbal Healer Academy, Inc.
127 McCain Drive
Mountain View
,
AR
72560
United States
Issuing Office:
Human & Animal Food Operations West Division 3
United States
Dear Ms. Huff:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS 570957 dated September 12, 2019). Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Jessica E. Havranek
Director, Compliance Branch
Human & Animal Food Operations, WD3
Content current as of:
05/12/2020
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Hieber's Pharmacy
MARCS-CMS 480933 —
May 01, 2020
Reference #:
15-PHI-20
Product:
Drugs
Recipient:
Recipient Name
Ms. Rosemary E. Mihalko, RPh
Recipient Title
Owner
Hieber's Pharmacy
3500 5th Avenue
Pittsburgh
,
PA
15213-3337
United States
Issuing Office:
Division of Pharmaceutical Quality Operations I
United States
(973) 331-4900
Dear Ms. Mihalko:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter #15-PHI-20, dated September 20, 2015, and our warning letter #542220, dated December 5, 2017. Based on our evaluation, it appears that you have adequately addressed the violations contained in these warning letters.
You are expected to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Diana Amador-Toro
Program Division Director
Office of Pharmaceutical Quality Operations
Division I/New Jersey District
Content current as of:
05/21/2020
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Hieber's Pharmacy
MARCS-CMS 542220 —
May 01, 2020
Product:
Drugs
Recipient:
Recipient Name
Ms. Rosemary E. Mihalko, RPh
Recipient Title
Owner
Hieber's Pharmacy
3500 5th Avenue
Pittsburgh
,
PA
15213-3337
United States
Issuing Office:
Office of Pharmaceutical Quality Operations Division I/New Jersey District
United States
(973) 331-4900
Dear Ms. Mihalko:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter #15-PHI-20, dated September 20, 2015, and our warning letter #542220, dated December 5, 2017. Based on our evaluation, it appears that you have adequately addressed the violations contained in these warning letters.
You are expected to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Diana Amador-Toro
Program Division Director
Office of Pharmaceutical Quality Operations
Division I/New Jersey District
Content current as of:
05/19/2020
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Hilgenkamp Farm Inc
MARCS-CMS 539250 —
July 30, 2020
Delivery Method:
VIA UPS
Recipient:
Recipient Name
Milton D. Hilgenkamp, Ronald G. Hilgenkamp
Recipient Title
Co-Owners
Hilgenkamp Farm Inc
8748 County Road 13
Arlington
,
NE
68002
United States
Issuing Office:
Office of Human and Animal Food Division II West
United States
913-495-5100
Dear Mr. Milton Hilgenkamp
and Mr. Ronald Hilgenkamp:
The Food and Drug Administration has completed an evaluation of Hilgenkamp Farms, Inc. corrective actions in response to our Warning Letter (CMS case #: 539250) on November 15, 2017. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Miguel A. Hernandez
Director, Compliance Branch
Office of Human and Animal Food
Division II West
Content current as of:
08/05/2020
CLOSEOUT LETTER
HMD Biomedical Inc.
MARCS-CMS 499698 —
September 02, 2020
Recipient:
Recipient Name
Tien-Tsai Hsu
Recipient Title
President
HMD Biomedical Inc.
No. 181 Minsheng St.
Xinpu Township
,
Hsinchu County
30548
Taiwan
Issuing Office:
"OHT7: Office of In Vitro Diagnostics and Radiological Health, Office of Product Evaluation and Quality"
United States
Dear Tien-Tsai Hsu:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #499698, dated August 31, 2016). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely yours,
/S/
Courtney H. Lias, Ph.D.
Deputy Director
OHT7: Office of In Vitro Diagnostics and
Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC:
Tina Jair
GL Diabetes Corp
9676 Oviedo St.
San Diego, CA 92129
Content current as of:
10/05/2020
CLOSEOUT LETTER
HoneyCombs Industries, LLC
MARCS-CMS 481691 —
March 18, 2020
Reference #:
DEN-16-06-WL
Product:
Dietary Supplements
Recipient:
Recipient Name
Ms. Jacqueline Huff
Recipient Title
General Manager
HoneyCombs Industries, LLC
10671 60.75 Road
Montrose
,
CO
81403
United States
Issuing Office:
Office of Human and Animal Food Operations Division IV West
United States
Dear Ms. Huff:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter DEN-16-06-WL dated February 24, 2016. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
LaTonya M. Mitchell, Ph.D.
Program Division Director
Office of Human and Animal Food Operations
Division IV West
Content current as of:
03/20/2020
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Invitrx Therapeutics, Inc
MARCS-CMS 514522 —
March 31, 2020
Delivery Method:
United Parcel Service
Reference #:
17-17
Recipient:
Recipient Name
Mr. Habib Torfi
Recipient Title
CEO/President
Invitrx Therapeutics, Inc
20503 Crescent Bay Dr.
Lake Forest
,
CA
92630
United States
Issuing Office:
Office of Human and Animal Food Operations West Division 5
United States
Dear Mr. Doe:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 17-17, dated February 27, 2017. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Sergio Chavez, Compliance Branch Director
Office of Human and Animal Food Operations
West Division 5
Content current as of:
04/13/2020
CLOSEOUT LETTER
The Jim Bakker Show
MARCS-CMS 604820 —
July 08, 2020
Product:
Dietary Supplements
Recipient:
Recipient Name
James Bakker
The Jim Bakker Show
180 Grace Chapel Rd.
Blue Eye
,
MO
65611
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park
,
MD
20740
United States
Dear James Bakker,
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our COVID-19 Warning Letter Re: 604820, issued March 06, 2020. Based on our evaluation, it appears you have addressed the violation(s) contained in the Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Carrie Lawlor
Branch Chief
Dietary Supplement and Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
07/15/2020
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Jubilant DraxImage Radiopharmacies, Inc.
MARCS-CMS 480877 —
June 04, 2020
Delivery Method:
UPS Next Day
Product:
Drugs
Recipient:
Recipient Name
Wayne Alexander, MBA
Recipient Title
Director, Quality
Jubilant DraxImage Radiopharmacies, Inc.
Triad Isotopes Inc.
4205 Vineland Road
Suite L1
Orlando
,
FL
32811
United States
Issuing Office:
Division of Pharmaceutical Quality Operations III
United States
(313) 393-8100
Dear Mr. Alexander:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter CMS #480877, dated March 10, 2016, for Triad Isotopes Inc. located at: 712 Westport Road, Kansas City, MO 64111. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.
It should be noted that effective September 1, 2017, Triad Isotopes, Inc. sold all of its assets to Jubilant DraxImage Radiopharmacies, Inc., including the “Triad Isotopes” name.
You are expected to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Nicholas F. Lyons
Director Compliance Branch
Division of Pharmaceutical Quality Operations III
Ph:
(312) 596-4220
Cc: Pramod Yadav, CEO
Jubilant Pharma Holdings Inc.
790 Township Line Rd., Suite 175
Yardley, PA 19067
Content current as of:
06/12/2020
Regulated Product(s)
Drugs
CLOSEOUT LETTER
K & S Food Center LLC
MARCS-CMS 542484 —
December 09, 2020
Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Dasrat Persaud, Ms. Kamlapattie Persaud
Recipient Title
Co-Owner/President, Co-Owner
K & S Food Center LLC
122 Park Ave.
Hartford
,
CT
06108-4036
United States
Issuing Office:
Office of Human and Animal Food Operations East Division 1
United States
Dear Mr. and Ms. Persaud:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS# 542484, issued on December 8, 2017. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
CDR Catherine Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
12/15/2020
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Kevin J. Klug
MARCS-CMS 588725 —
March 12, 2020
Delivery Method:
VIA UPS
Recipient:
Recipient Name
Kevin J. Klug
Recipient Title
Owner
Kevin J. Klug
56628 893rd Rd
Wynot
,
NE
68792-3009
United States
Issuing Office:
Office of Human and Animal Food Division II West
United States
913-495-5100
Dear Mr. Kevin J. Klug:
The Food and Drug Administration has completed an evaluation of Kevin J. Klug corrective actions in response to our Warning Letter (CMS case #: 588725) on September 23, 2019. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Miguel A. Hernandez
Director, Compliance
Office of Human and Animal Food – Division II West
Content current as of:
03/18/2020
CLOSEOUT LETTER
La Vita Compounding Pharmacy, LLC
MARCS-CMS 575286 —
September 03, 2020
Delivery Method:
Electronic Mail
Recipient:
Recipient Name
Christine A. Givant
Recipient Title
Pharmacist in Charge
La Vita Compounding Pharmacy, LLC
3978 Sorrento Valley Boulevard
Suite 300
San Diego
,
CA
92121-1436
United States
Issuing Office:
Division of Pharmaceutical Quality Operations IV
United States
Dear Ms. Givant:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (CMS No. 575286) dated February 28, 2019. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.
You are expected to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
Content current as of:
09/15/2020
CLOSEOUT LETTER
Lake Fish Company Inc
MARCS-CMS 489196 —
April 01, 2020
Recipient:
Recipient Name
Mr. Dale D. Trent
Recipient Title
President
Lake Fish Company Inc
1014 W Water Street
Sandusky
,
OH
44870
United States
Issuing Office:
HAF East Division V
United States
(513) 679-2700
Dear Mr. Trent:
The Food and Drug Administration has completed an evaluation of your firms’ corrective actions in response to our Warning Letter (CIN-16-489196-09) issued on February 17, 2016. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Allison C. Hunter
Compliance Officer
HAF East Division V
Content current as of:
04/10/2020