tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Beauty & Health International Inc.
MARCS-CMS 479921 —
January 14, 2020
Delivery Method:
United Parcel Service
Reference #:
21-16
Product:
Dietary Supplements
Recipient:
Recipient Name
Dr. Charles G. Myung
Recipient Title
President
Beauty & Health International Inc.
7541 Anthony Avenue
Garden Grove
,
CA
92841-4005
United States
Issuing Office:
Office of Human and Animal Food Operations West Division 5
United States
Dear Dr. Myung:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #21-16 dated February 5, 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/
Sergio Chavez, Compliance Branch Director
Office of Human and Animal Food Operations
West Division 5
Content current as of:
01/22/2020
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Biotek, Inc.
MARCS-CMS 539361 —
July 08, 2020
Product:
Dietary Supplements
Recipient:
Recipient Name
Norman J. Larsen
Recipient Title
President
Biotek, Inc.
334 Marshall Way N
Suite F
Layton
,
UT
84041
United States
Issuing Office:
Office of Human and Animal Foods Division IV West
United States
Dear Mr. Larsen:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, reference # HAF4W (DEN)-18-04-WL, issued March 13, 2018. Based on our evaluation, it appears that you have addressed the violation(s) contained in the referenced 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.
Denver District Director
Program Division Director
Office of Human and Animal Foods
Division IV West
Content current as of:
07/08/2020
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Bisket Vapes, LLC
MARCS-CMS 592384 —
November 02, 2020
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
RW1901182
Recipient:
Recipient Name
Kenneth George
Bisket Vapes, LLC
18218 Paradise Mountain Road
Room 68
Valley Center
,
CA
92082
United States
info@bisketvapes.com
kenny.56@hotmail.com
Issuing Office:
Division of Promotion, Advertising, and Labeling
United States
Dear Kenneth George:
The United States Food and Drug Administration’s (FDA) Center for Tobacco Products has completed an evaluation of your corrective actions in response to our Warning Letter dated September 24, 2019. Based on our evaluation, it appears that you have taken steps to address the violations contained in the Warning Letter regarding your website https://bisketvapes.com.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. This letter also will not preclude any regulatory action should violations be observed in the future.
Sincerely,
/S/
David Rice
Branch Chief
Division of Promotion, Advertising, and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA UPS
cc:
BisketVapes, LLC
5025 Golden Antelope Way
Las Vegas, NV 89139
Bisket Vapes, LLC
2003 David Dr.
Escondido, CA 92026-1010
Content current as of:
11/25/2020
CLOSEOUT LETTER
Blis Caviar LLC
MARCS-CMS 488262 —
September 04, 2020
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Steven Stallard
Recipient Title
President
Blis Caviar LLC
3759 Broadmoor Avenue SE
Kentwood
,
MI
49512
United States
Issuing Office:
Human and Animal Food Division East 6
United States
Dear Mr. Stallard:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 2016-DET-06. 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/
Kathryn A. Cutajar
Compliance Officer
FDA Human and Animal Food Division East 6
Content current as of:
09/11/2020
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Boule Medical AB
MARCS-CMS 559614 —
February 26, 2020
Product:
Medical Devices
Recipient:
Recipient Name
Christina Rubenhag
Recipient Title
Acting Chief Executive Officer
Boule Medical AB
Domnarvsgatan 4
Spanga
163 53
Stockholms Lan
Sweden
Issuing Office:
Office of In Vitro Diagnostics and Radiological Health
United States
Dear Ms. Rubenhag:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CMS # 559614] dated October 2, 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/
Courtney H. Lias, Ph.D.
Deputy Director for
Patient Safety and Product Quality
Office of In Vitro Diagnostics and Radiological
Health
Center for Devices and Radiological Health
CC (US Agent):
Deborah A. Herrera
Clinical Diagnostic Solutions, Inc.
1800 NW 65th Avenue
Plantation, Florida 33313
Content current as of:
03/04/2020
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Brad D. Smith
MARCS-CMS 596961 —
July 22, 2020
Delivery Method:
VIA UPS
Recipient:
Recipient Name
Brad D. Smith
Brad D. Smith
3741 220th St
Estherville
,
IA
51334-7621
United States
Issuing Office:
Office of Human and Animal Food –
United States
913-495-5100
Dear Mr. Brad D. Smith:
The Food and Drug Administration has completed an evaluation of Brad D. Smith corrective actions in response to our Warning Letter (CMS case #: 596961) 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:
10/16/2020
CLOSEOUT LETTER
Burren Smokehouse Ltd.
MARCS-CMS 584335 —
April 06, 2020
Recipient:
Recipient Name
Ms. Birgitta Hedin Curtin
Recipient Title
Managing Director
Burren Smokehouse Ltd.
Kincora Road
Lisdoonvarna
Co. Clare
V95 HD70
Ireland
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Ms. Curtin:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #584335 July 30, 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/
Robyn R. Jones
Food Adulteration Assessment Branch
Division of Enforcement
Office of Compliance
Content current as of:
04/13/2020
CLOSEOUT LETTER
Cane S.p.A.
MARCS-CMS 453171 —
March 06, 2020
Recipient:
Recipient Name
Claudio Cane
Recipient Title
Managing Director
Cane S.p.A.
Via Cuorgné, 42/a
Rivoli
10098
Turin
Italy
Issuing Office:
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Mr. Cane:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective and preventive actions in response to our Warning Letter (WL) dated July 29, 2015. Based on our evaluation, it appears that your firm has adequately addressed the violations contained in this WL.
This letter does not relieve your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(h), and its implementing regulations. The FDA expects your firm to maintain compliance and this letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely yours,
/S/
Tina Kiang, Ph.D.
Director
Division of Drug Delivery and General Hospital
Devices and Human Factors
Office of Gastrorenal, ObGyn, General Hospital
and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Content current as of:
03/12/2020
CLOSEOUT LETTER
Carolina Liquid Chemistries Corp
MARCS-CMS 573596 —
November 02, 2020
Delivery Method:
VIA Electronic Mail
Recipient:
Recipient Name
Patricia A.G. Shugart, Philip Shugart
Recipient Title
Chief Operating Officer, CEO
Carolina Liquid Chemistries Corp
313 Gallimore Dairy Rd.
Greensboro
,
NC
27409
United States
pattigaull@aol.com
Issuing Office:
Office of Medical Devices and Radiological Health Operations Division 3/West
United States
Dear Ms. & Mr. Shugart,
The Food and Drug Administration has completed an evaluation of your corrective actions in response to a Warning Letter dated 7/31/2019. 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/
Jessica Mu
Compliance Branch Director
Office of Medical Devices and Radiological Health Operations
Division 3/West
Content current as of:
11/18/2020
CLOSEOUT LETTER
Celloxess LLC
MARCS-CMS 495253 —
February 11, 2020
Reference #:
16-NWJ-11
Product:
Dietary Supplements
Drugs
Recipient:
Recipient Name
Dr. Parviz Gharagozloo
Celloxess LLC
830 Bear Tavern Rd
Ewing
,
NJ
08628
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Dr. Gharagozloo:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, 16-NWJ-11, dated July 22, 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,
Carrie Lawlor
/S/
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:
02/18/2020
Regulated Product(s)
Dietary Supplements
Drugs
CLOSEOUT LETTER
Cenorin, LLC
MARCS-CMS 434408 —
May 20, 2020
Reference #:
WL SEA 15-09
Product:
Medical Devices
Recipient:
Recipient Name
Mr. Fredric R. Radford
Recipient Title
CEO
Cenorin, LLC
6324 South 199th Place
Suite 107
Kent
,
WA
98032
United States
rradford@cenorin.com
Issuing Office:
Office of Medical Device and Radiological Health Operations (Division 3W)
United States
Dear Mr. Radford:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [WL SEA 15-09 dated February 12, 2015]. 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 Mu
Director of Compliance Branch
Office of Medical Device and Radiological Health
Division 3/West
Content current as of:
05/26/2020
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Center for New Medicine/Perfectly Healthy by Connealy MD
MARCS-CMS 605804 —
July 06, 2020
Product:
Dietary Supplements
Drugs
Recipient:
Recipient Name
Dr. Leigh Erin Connealy
Center for New Medicine/Perfectly Healthy by Connealy MD
6 Hughes, Suite 100
Irvine
,
CA
92618
United States
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park
,
MD
20740
United States
Dear: Dr. Leigh Erin Connealy,
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: 605804, issued May 13, 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 J. Lawlor
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:
07/10/2020
Regulated Product(s)
Dietary Supplements
Drugs
CLOSEOUT LETTER
Central Admixture Pharmacy Services Inc
MARCS-CMS 497021 —
May 27, 2020
Product:
Drugs
Recipient:
Recipient Name
Thomas J. Wilverding
Recipient Title
President
Central Admixture Pharmacy Services Inc
6800 Aston Street
Suite 150
Irvine
,
CA
92606
United States
Issuing Office:
Division of Pharmaceutical Quality Operations IV
United States
(949) 608-2900
Dear Mr. Wilverding:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter # 40-16, issued August 18, 2016. 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:
06/12/2020
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Central Admixture Pharmacy Services, Inc.
MARCS-CMS 498479 —
June 17, 2020
Delivery Method:
Certified Email
Product:
Drugs
Recipient:
Recipient Name
Thomas J. Wilverding
Recipient Title
President
Central Admixture Pharmacy Services, Inc.
6580 Snowdrift Road
Suite 100
Allentown
,
PA
18106-9331
United States
Issuing Office:
Division of Pharmaceutical Quality Operations I
United States
(973) 331-4900
Dear Mr. Wilverding:
We are enclosing a copy of the Establishment Inspection Report (EIR) for the inspection conducted at your facility, Central Admixture Pharmacy Services, Inc., located at 6580 Snowdrift Road, Suite 100, Allentown, PA 18106-9331, from July 30, 2018, to August 22, 2018, by the U.S. Food and Drug Administration (FDA). We are also releasing a copy of the Establishment Inspection Report (EIR)s for the inspections conducted August 29, 2016, to September 19, 2016, February 3, 2015 to February 11, 2015, and June 4, 2014, to June 11, 2014.
When the Agency concludes that an inspection is “closed” under 21 C.F.R. 20.64(d)(3), it will release a copy of the EIR to the inspected establishment.
The Agency continually works to make its regulatory process and activities more transparent for regulated industry. Releasing this EIR to you is part of this effort. The copy being provided to you comprises the narrative portion of the report; it may reflect redactions made by the Agency in accordance with the Freedom of Information Act (FOIA) and 21 C.F.R. Part 20. This, however, does not preclude you from requesting and possibly obtaining any additional information under FOIA.
If there is any question about the released information, please contact Yvette Johnson, Compliance Officer at
Yvette.Johnson@fda.hhs.gov
.
Sincerely,
/S/
Stephanie Durso, Compliance Branch Director
Office of Pharmacy Quality Operations, Division I
Content current as of:
06/23/2020
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Chen Shwezin, Inc. dba Park Compounding Pharmacy
MARCS-CMS 496320 —
July 20, 2020
Delivery Method:
Via Email
Recipient:
Recipient Name
Justin Y. Chen
Recipient Title
Owner
Chen Shwezin, Inc. dba Park Compounding Pharmacy
4333 Park Terrance Drive
Suite 160
Westlake Village
,
CA
91361
United States
Issuing Office:
Division of Pharmaceutical Quality Operations IV
United States
949-608-2900
Dear Mr. Chen:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (WL #20-17), dated March 15, 2017. We acknowledge that your firm no longer produces sterile drug products. 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:
08/05/2020
CLOSEOUT LETTER
Chi's Enterprise Inc
MARCS-CMS 542724 —
April 08, 2020
Reference #:
542724-18
Product:
Dietary Supplements
Recipient:
Recipient Name
Ms. Weijia D. Chi
Recipient Title
President and Owner
Chi's Enterprise Inc
1435 North Brasher St.
Anaheim
,
CA
92807
United States
Issuing Office:
Office of Human and Animal Food Operations West Division 5
United States
Dear Ms. Chi:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #542724-18 dated April 30, 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/
Sergio Chavez, Compliance Branch Director
Office of Human and Animal Food Operations
West Division 5
Content current as of:
04/24/2020
Regulated Product(s)
Dietary Supplements