tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma 2
MARCS-CMS 487023 —
September 11, 2019
Delivery Method:
UPS Next Day
Signature Required
Reference #:
# CHI-8-16
Product:
Drugs
Recipient:
Recipient Name
William J. Kalman
Recipient Title
President and Co-Owner
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma 2
4625 N University Street
Peoria
,
IL
61614-5828
United States
Issuing Office:
Division of Pharmaceutical Quality Operations III (PHRM3)
300 River Place
Suite 5900
Detroit
,
MI
48207
United States
(313) 393-8100
Dear Mr. Kalman:
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 # CHI-8-16), dated July 22, 2016. 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 assure 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
Compliance Director
Division of Pharmaceutical Quality Operations III
Content current as of:
09/23/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Kaltec Food Packaging Inc.
MARCS-CMS 553493 —
July 18, 2019
Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
Harriet L. Mascara
Recipient Title
CEO
Kaltec Food Packaging Inc.
36-40 Center St.
Port Jervis
,
NY
12771
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
158-15 Liberty Avenue
Jamaica
,
NY
11433
United States
Dear Ms. Mascara:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS# 553493, issued on June 8, 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/
CDR Catherine Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
07/22/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Kenneth O. Lester Co. Inc., dba PFG Customized Distribution
MARCS-CMS 539243 —
May 14, 2019
Delivery Method:
UPS Overnight
Reference #:
2018-DAL-WL-01
Product:
Food & Beverages
Recipient:
Recipient Name
Craig H. Hoskins
Recipient Title
President and CEO
Kenneth O. Lester Co. Inc., dba PFG Customized Distribution
Performance Food Group Customized
12500West Creek Parkway
Richmond
,
VA
23238
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Hoskins,
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (Ref: 2018-DAL-WL-01), dated October 12, 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 asses 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. If you choose to reestablish or sell your operations, 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 Hensley
Director of Compliance
Office of Human and Animal Food, WD3
Cc:  Mr. Jeffrey A. Jackson, Warehouse Manager
Performance Food Group Inc.
500 Metro Park Drive
McKinney, TX 75071-1883
Mr. Tom Hoeffel, Regional Vice President
Performance Food Group Inc.
500 Metro Park Drive
McKinney, TX 75071-1883
Content current as of:
05/20/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Kerry Inc.
MARCS-CMS 577100 —
August 20, 2019
Delivery Method:
UPS
Product:
Food & Beverages
Seafood/Seafood Product
Recipient:
Recipient Name
Gregory T. Irby
Recipient Title
Plant Manager
Kerry Inc.
7401 Will Rogers Blvd.
Fort Worth
,
TX
76140
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
4040 North Central Expressway
Suite 300
Dallas
,
TX
75204-3138
United States
Dear Mr. Irby:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (CMS Case #: 577100) issued on April 2, 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/
Casey Hamblin
Recall Coordinator/Compliance Officer
Office of Human and Animal Food-West Div. 3
Content current as of:
08/21/2019
Regulated Product(s)
Food & Beverages
Seafood/Seafood Product
CLOSEOUT LETTER
Kings Park Slope Inc.
MARCS-CMS 439314 —
November 15, 2019
Delivery Method:
VIA UNITED PARCEL SERVICE
Reference #:
NYK 2015-28
Product:
Drugs
Recipient:
Recipient Name
Dmitry Vagman
Recipient Title
VP & Pharmacist in Charge
Kings Park Slope Inc.
Kings Super Pharmacy/Kings Pharmacy
357 Flatbush Avenue
Brooklyn
,
NY
11238
United States
Issuing Office:
Division of Pharmaceutical Quality Operations I
10 Waterview Blvd
3rd FL
Parsippany
,
NJ
07054
United States
(973) 331-4900
Dear Mr. Vagman:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter NYK 2015-28, dated March 27, 2015. We acknowledge that Kings Park Slope, Inc. registered with FDA as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) on December 23, 2013, and officially de-registered on July 21, 2017.
You are expected to take all necessary steps to ensure compliance with the FDCA 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.
Send your electronic inquiries to
orapharm1_responses@fda.hhs.gov
. Please identify your communication with FEI #3007174596.
If you have any questions, contact Compliance Officer Juan Jimenez at
juan.jimenez@fda.hhs.gov
or call
1-518-453-2314
X-1014.
/S/
Craig Swanson
Acting Program Division Director/District Director
U.S. Food and Drug Administration
OPQO Division I / New Jersey District
Content current as of:
02/03/2020
Regulated Product(s)
Drugs
CLOSEOUT LETTER
KPC Products Inc
MARCS-CMS 548695 —
June 05, 2019
Product:
Food & Beverages
Recipient:
Recipient Name
Jason Tsai
Recipient Title
President
KPC Products Inc
16 Goddard
Irvine
,
CA
92618
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Tsai:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 548695 issued June 20, 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
Division 5 West
Content current as of:
06/12/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Lakeview Dairy, LLC
MARCS-CMS 565303 —
May 30, 2019
Product:
Animal & Veterinary
Recipient:
Recipient Name
Michael D. Roecker, Bruce G. Walker
Recipient Title
Co-owners
Lakeview Dairy, LLC
Mayville Animal Clinic S.C., White Diamond Dairy, LLC
N8783 Basswood Road
Beaver Dam
,
WI
53916-9352
United States
Issuing Office:
Center for Veterinary Medicine
250 Marquette Avenue
Suite 600
Minneapolis
,
MN
55401
United States
612) 334-4100
Dear Messrs. Roecker and Walker:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 565303 dated October 19, 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/
Dianna C. Sonnenburg
Compliance Officer, West Division 1 - CB
Office of Human and Animal Foods Operations
Content current as of:
06/10/2019
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
LaMarquise Inc.
MARCS-CMS 558211 —
October 15, 2019
Product:
Food & Beverages
Recipient:
Recipient Name
Tadeusz J. Wielezynski
Recipient Title
Owner
LaMarquise Inc.
1550 W. Lane Avenue
Upper Arlington
,
OH
43221-3921
United States
Issuing Office:
Cincinnati District Office
6751 Steger Drive
Cincinnati
,
OH
45237
United States
513) 679-2700
Dear Mr. Wielezynski:
The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter 558211, issued February 5, 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/
Kimberly Dutzek
Compliance Officer, Division V
Office of Human and Animal Foods Operations-East
Content current as of:
10/21/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Laser Dental Innovations
MARCS-CMS 546341 —
June 04, 2019
Delivery Method:
UPS Overnight
Product:
Medical Devices
Recipient:
Recipient Name
Howard A. Feinberg
Recipient Title
President
Laser Dental Innovations
1219 Quail Creek Circle
San Jose
,
CA
95120
United States
Issuing Office:
Center for Devices and Radiological Health
19701 Fairchild
Irvine
,
CA
92612
United States
Dear Mr. Feinberg:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated February 27, 2018. 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/
For Bryan Love
Acting Director, Compliance Branch
Content current as of:
06/05/2019
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Lavian Ltd
MARCS-CMS 495981 —
April 30, 2019
Delivery Method:
United Parcel Service
Product:
Dietary Supplements
Food & Beverages
Recipient:
Recipient Name
Amos Lavian
Recipient Title
President
Lavian Ltd
960 South Broadway
Suite 122
Hicksville
,
NY
11801
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Lavian:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter NYK-2016-39, issued on 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,
/S/
CDR Catherine Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1
Content current as of:
05/07/2019
Regulated Product(s)
Dietary Supplements
Food & Beverages
CLOSEOUT LETTER
Legendary Nutrition, LLC
MARCS-CMS 486995 —
November 26, 2019
Product:
Dietary Supplements
Recipient:
Recipient Name
Dave Rodely
Legendary Nutrition, LLC
361 Southwest Drive #136
Jonesboro
,
AR
72401
United States
Issuing Office:
Division of Enforcement
United States
Dear Mr. Dave Rodely:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter #486995, issued March 7, 2016. Based on our evaluation, it appears you have addressed the violations 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:
05/21/2020
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
Liberty Drug & Surgical
MARCS-CMS 485027 —
February 25, 2019
Delivery Method:
UPS Next Day Air
Recipient:
Recipient Name
Alan Brown
Recipient Title
President
Liberty Drug & Surgical
Liberty Drug & Surgical
195 Main Street
Chatham
,
NJ
07928
United States
Issuing Office:
Center for Drug Evaluation and Research
United States
Dear Mr. Brown:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter # 16-NWJ-05 dated March 14, 2016. We acknowledge that your firm no longer produces sterile drug products and in the absence of a valid patient-specific prescription or medication order, shall not prepare compounded non-sterile preparations for human use except to the extent permitted by Federal law. 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 assure 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
Content current as of:
03/11/2019
CLOSEOUT LETTER
Line One Nutrition, Inc
MARCS-CMS 562618 —
June 19, 2019
Product:
Dietary Supplements
Recipient:
Recipient Name
Andrew Dean McMichael
Recipient Title
President
Line One Nutrition, Inc
2607 N. River Hills Rd.
Austin
,
TX
78733
United States
Issuing Office:
CFSAN Office of Compliance
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Mr. McMichael:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, CMS #562618, dated April 10, 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/
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:
10/08/2019
Regulated Product(s)
Dietary Supplements
CLOSEOUT LETTER
MA Labs LLC
MARCS-CMS 566831 —
June 04, 2019
Product:
Food & Beverages
Recipient:
Recipient Name
Mike Arnold
MA Labs LLC
7970 Mentor Ave
Room N3
Mentor
,
OH
44060
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Arnold:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 566831, issued November 7, 2018. Based on our evaluation, it appears you have addressed the violations 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 Supplements and Labeling Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
06/06/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Mac Vapes LLC d/b/a Oishi Jusu
MARCS-CMS 585031 —
November 13, 2019
Delivery Method:
VIA UPS and Electronic Mail
Reference #:
RW1901116
Product:
Tobacco
Recipient:
Recipient Name
Frederick McCullough
Mac Vapes LLC d/b/a Oishi Jusu
361 Cleveland Place
Suite 105
Virginia Beach
,
VA
23462
United States
oishijusu@gmail.com
Issuing Office:
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Frederick McCullough:
On August 8, 2019, the United States Food and Drug Administration's (FDA) Center for Tobacco Products (CTP) issued a Warning Letter to you informing you that your The Ronins e-liquid tobacco product is misbranded because its labeling does not display the required nicotine warning statement in the manner required by 21 C.F.R. § 1143.3.
We acknowledge receipt of your e-mail correspondences dated August 8, 2019 and September 12, 2019, regarding the Warning Letter and corrective actions taken. In addition, FDA held a teleconference with you on September 11, 2019 to provide clarification regarding the Warning Letter. Based on our evaluation, it appears that you have taken steps to address the violations identified in the Warning Letter.
This letter does not relieve you or your firm from the responsibility of taking all necessary steps to ensure sustained compliance with the FD&C 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/
Ele Ibarra-Pratt
Director
Division of Promotion, Advertising and Labeling
Office of Compliance and Enforcement
Center for Tobacco Products
VIA Electronic Mail
cc:
GoDaddy.com, LLC
abuse@godaddy.com
Google LLC
google-cloud-compliance@google.com
Content current as of:
11/19/2019
Regulated Product(s)
Tobacco