tim-a-wood/fda-warning-letters huggingface dataset:
CLOSEOUT LETTER
Premier Produce LLC
MARCS-CMS 553107 —
May 31, 2019
Product:
Food & Beverages
Fruit/Fruit Product
Recipient:
Recipient Name
Marvin T. Harned
Recipient Title
Owner
Premier Produce LLC
2521 Ring Road
Elizabethtown
,
KY
42701-9107
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
(513) 679-2700
Dear Mr. Harned:
The Food and Drug Administration (FDA) completed an evaluation of your firm's corrective actions in response to our Warning Letter No. 553107.  Based on our evaluation, it appears 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 also serves as acknowledgement to your firm responses dated February 2, 2019, and May 27, 2019, addressing corrective actions taken to a Form FDA 483, Inspectional Observations, issued to your firm on January 31, 2019, during a follow-up inspection.  Your response indicates that you have corrected the deficiencies noted by our investigator on the Form FDA 483. We will verify the effectiveness of your corrective actions during a future inspection of your facility.
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/
Zada L. Giles
Compliance Officer, Division V
Office of Human and Animal Foods Operations-East
Content current as of:
06/03/2019
Regulated Product(s)
Food & Beverages
Fruit/Fruit Product
CLOSEOUT LETTER
Provitus Dabrowscy, Malesa S.J.
MARCS-CMS 433918 —
November 22, 2019
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Stanislaw Dabrowski
Recipient Title
Owner
Provitus Dabrowscy, Malesa S.J.
ul. Weteranów 149
05-250
Radzymin
Poland
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Mr. Dabrowski:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #433918, issued on July 17, 2014 and your firm’s petitions to be removed from the Red List of Import Alert #99-38. 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/
Robyn R. Jones
Team Lead
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
11/27/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
PT. Primo Indo Ikan
MARCS-CMS 581917 —
August 28, 2019
Delivery Method:
Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Lucas J. Papierniak
Recipient Title
Director
PT. Primo Indo Ikan
888 Moaniala Street
Honolulu
,
HI
96821-2548
United States
lucasp@primoindoikan.com
Issuing Office:
Center for Food Safety and Applied Nutrition
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Mr. Papierniak:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 581917, issued May 30, 2019. 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/
Maria G. Corpuz, Team Leader
Food Adulteration and Assessment Branch
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
08/30/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
PT. SIG ASIA
MARCS-CMS 592584 —
December 17, 2019
Product:
Food & Beverages
Seafood/Seafood Product
Recipient:
Recipient Name
Shaun Tan
Recipient Title
Chairwoman
PT. SIG ASIA
Jl. Lumba-Lumba Lingkungan IV, RT. 01, RW. 04
Kel. Girian Bawah, Kec. Girian
Bitung
Sulawesi Utara
95542
Indonesia
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
5001 Campus Drive
College Park
,
MD
20740
United States
Dear Ms. Tan:
The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #592584, issued October 28, 2019. 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/
Mildred P. Benjamin
Branch Chief
Division of Enforcement
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
03/09/2020
Regulated Product(s)
Food & Beverages
Seafood/Seafood Product
CLOSEOUT LETTER
Pulmuone Foods USA, Inc.
MARCS-CMS 416366 —
September 30, 2019
Product:
Food & Beverages
Seafood/Seafood Product
Recipient:
Recipient Name
Hyoyul Lee
Recipient Title
North American Business Unit CEO
Pulmuone Foods USA, Inc.
2315 Moore Ave
Fullerton
,
CA
92833
United States
Issuing Office:
Office of Human and Animal Food Operations – West Division 5
1201 Harbor Bay Parkway
Alameda
,
CA
94502
United States
Dear Hyoyul Lee:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, dated February 6, 2014. 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/
For: Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations – West Division 5
Content current as of:
10/04/2019
Regulated Product(s)
Food & Beverages
Seafood/Seafood Product
CLOSEOUT LETTER
Pure Nootropics, LLC
MARCS-CMS 565425 —
June 04, 2019
Product:
Dietary Supplements
Recipient:
Recipient Name
Christopher Dziak
Pure Nootropics, LLC
10532 Figaro Dr Nw
Albuquerque
,
NM
87114-3890
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
Dear Mr. Dziak:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter# 565425, issued February 5, 2019. 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)
Dietary Supplements
CLOSEOUT LETTER
Pure Source LLC
MARCS-CMS 555240 —
November 15, 2019
Delivery Method:
VIA UPS
Product:
Drugs
Recipient:
Recipient Name
Joel J. Meyerson
Recipient Title
Owner
Pure Source LLC
9750 NW 17th Street
Doral
,
FL
33172-2753
United States
Issuing Office:
Center for Drug Evaluation and Research
United States
Mr. Meyerson:
The Food and Drug Administration has completed the evaluation of corrective actions in response to our Warning Letter (WL # 555240), dated February 20, 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/
John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II
CC: Renee Alsobrook, Chief
Department of Business and Professional Regulation
Division of Drugs, Devices and Cosmetics
Compliance and Enforcement
2601 Blair Stone Road
Tallahassee, Florida 32399-1047
Content current as of:
11/19/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
RadLogics, Inc.
MARCS-CMS 515599 —
October 29, 2019
Product:
Medical Devices
Recipient:
Recipient Name
Moshe Becker
Recipient Title
CEO
RadLogics, Inc.
24 Westland Ave. #28
Boston
,
MA
02115
United States
Issuing Office:
Office of In Vitro Diagnostics and Radiological Health
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
Dear Mr. Becker:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS 515599. 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/
Thalia T. Mills, Ph.D.
Director
Division of Radiological Health
OHT7: Office of In Vitro Diagnostics and Radiological Health
Office of Product Engineering and Quality
Center for Devices and Radiological Health
Content current as of:
11/05/2019
Regulated Product(s)
Medical Devices
CLOSEOUT LETTER
Ratzlaff Ranch Inc.
MARCS-CMS 497546 —
April 23, 2019
Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Mike (NMI) Zarras
Recipient Title
President
Ratzlaff Ranch Inc.
Apple-A-Day
13200 Occidental Road
Sebastopol
,
CA
95472
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
510-337-6700
Dear Mr. Mike (NMI) Zarras:
The Food and Drug Administration has completed an evaluation of Regalo’s Favorite of Hawaii, Inc. corrective actions in response to our Warning Letter 497546 dated April 26, 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/
Sergio Chavez, Compliance Branch Director
Office of Human and Animal Food
Division 5 West
Content current as of:
05/07/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
RC Compounding Services, LLC
MARCS-CMS 393791 —
September 12, 2019
Delivery Method:
UPS Next Day
Reference #:
CIN-14-393791-17
Product:
Drugs
Recipient:
Recipient Name
Raymond R. Carlson, RPh
Recipient Title
Owner/Pharmacist
RC Compounding Services, LLC
3030 Center Road
Poland
,
OH
44514
United States
Issuing Office:
Division of Pharmaceutical Quality Operations III
300 River Place
Suite 5900
Detroit
,
MI
48207
United States
(313) 393-8100
Dear Mr. Carlson,
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter dated July 14, 2014 (CIN-14-393791-17). 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/
Nicholas F. Lyons
Director Compliance Branch
Division of Pharmaceutical Quality Operations III
Content current as of:
10/24/2019
Regulated Product(s)
Drugs
CLOSEOUT LETTER
Regalo's Favorite of Hawaii Inc.
MARCS-CMS 508259 —
April 05, 2019
Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Ruby Ho
Recipient Title
President
Regalo's Favorite of Hawaii Inc.
421 N. King Street
Honolulu
,
HI
96812
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
1431 Harbor Bay Parkway
Alameda
,
CA
94502
United States
510-337-6700
Dear Ms. Ruby Ho:
The Food and Drug Administration has completed an evaluation of Regalo’s Favorite of Hawaii, Inc. corrective actions in response to our Warning Letter 508259 dated December 28, 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/
for/
Sergio Chavez, Compliance Branch Director
Office of Human and Animal Food
Division 5 West
Content current as of:
04/11/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Reser's Fine Foods Inc.
MARCS-CMS 487641 —
October 31, 2019
Reference #:
16-ATL-11
Product:
Food & Beverages
Recipient:
Recipient Name
Mark A. Reser
Recipient Title
President & CEO
Reser's Fine Foods Inc.
15570 SW Jenkins Road
Beaverton
,
OR
97006
United States
Issuing Office:
Office of Human and Animal Foods- Division 3 East
60 Eighth Street N.E.
Atlanta
,
GA
30309
United States
Dear Mr. Reser,
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (16-ATL-11 dated July 1, 2016). Based on our evaluation during the May 2-6, 2017 visit to your facility located at 11251 NC Highway 903, Halifax, NC 27839-9073, it appears that 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.
If you have any questions regarding this letter, you may contact Janice L. King, Compliance Officer, U.S. Food and Drug Administration, 4600 Goer Drive, #106, North Charleston, SC 29406. You may also contact Ms. King at
(843) 746-2990
x16 or via email at
Janice.king@fda.hhs.gov
.
Sincerely,
/S/
Janice L. King
Compliance Officer
U.S. Food & Drug Adminisration
Office of Human and Animal Foods- Division 3 East
(Georgia- North Carolina-South Carolina)
CC: Kenneth R. Braswell, General Manager
Reser's Fine Foods1 Inc.
11251 NC Highway 903
Halifax, NC 27839-9073
Content current as of:
11/04/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Rico-Perez Products, Inc.
MARCS-CMS 547180 —
April 09, 2019
Delivery Method:
VIA UNITED PARCEL SERVICE
Reference #:
18-HAFE4-WL-03
Product:
Food & Beverages
Recipient:
Recipient Name
Carlos Rico
Recipient Title
Co-owner and Manager
Rico-Perez Products, Inc.
2295 Coral Way
Coral Gables
,
FL
33145
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
466 Avenida Fernández Juncos
San Juan
00901-3223
Puerto Rico
(787) 729-8500
Dear Mr. Rico:
The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to Warning Letter 18-HAFE4-WL-03 dated May 18, 2018. It appears your firm has 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.
Kind regards,
/S/
Edwin Ramos
Director of Compliance Branch OHAFO, Division IV East
Content current as of:
04/12/2019
Regulated Product(s)
Food & Beverages
CLOSEOUT LETTER
Roorda Dairy
MARCS-CMS 556590 —
April 08, 2019
Delivery Method:
VIA UPS
Product:
Animal & Veterinary
Recipient:
Recipient Name
Larry Roorda, Scott Roorda, Lance Roorda
Recipient Title
Co-Owners
Roorda Dairy
5128 460th St.
Paullina
,
IA
51046
United States
Issuing Office:
Center for Veterinary Medicine
8050 Marshall Drive
Suite 205
Lenexa
,
KS
66214-1524
United States
913-495-5100
Dear Messrs. Larry Roorda, Scott Roorda and Lance Roorda:
The Food and Drug Administration has completed an evaluation of Roorda Dairy, LLC corrective actions in response to our Warning Letter (CMS case #: 556590) on July 9, 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/
Miguel A. Hernandez
Director, Compliance
Office of Human and Animal Food – Division II West
Content current as of:
04/12/2019
Regulated Product(s)
Animal & Veterinary
CLOSEOUT LETTER
RTI Surgical, Inc. dba RTI Biologics, Inc.
MARCS-CMS 525318 —
April 12, 2019
Recipient:
Recipient Name
Mr. Camille Farhat
Recipient Title
President and CEO
RTI Surgical, Inc. dba RTI Biologics, Inc.
11621 Research Circle
Alachua
,
FL
32615
United States
Issuing Office:
Center for Biologics Evaluation and Research (CBER)
555 Winderley Place
Suite 200
Maitland
,
FL
32751
United States
Dear Mr. Farhat:
The Food and Drug Administration has completed an evaluation of your firm's actions in response to our Warning Letter [OBPO-1 18-01] dated, November 8, 2017, for adulteration and misbranding of a drug product. Based on our evaluation of your firm's manufacturing and distribution operations on November 27, 2018, the Agency acknowledges that you have ceased manufacturing and distributing the map3 Allograft product. We acknowledge that you voluntarily discarded through incineration, your remaining inventory of map3 Allograft product under FDA observation on December 19, 2018. Because your firm is no longer performing the activities specified in the Warning Letter, you are no longer required to implement corrective actions to address the violations at this time. However, if your firm resumes operations as described in the Warning Letter, it must be in full compliance with current good manufacturing practices and address all the concerns described in the Warning Letter.
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. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
Sincerely,
/S/
Elizabeth Waltrip
Program Division Director
Content current as of:
08/05/2020