DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website
DA, Elizabeth Jungman, J.D., M.P.H. Chief of Staff of the FDA | Official Website
This is a 35.7% increase over the number of companies cited in the previous year.
Of the 77 citations issued, the most common citations include:
- You did not keep the grounds around your plant in a condition that would protect against the contamination of food.
- You did not maintain your plant in a clean and sanitary condition and in adequate repair.
- You did not exclude pests from your food plant to protect against contamination of food.
Most of the companies cited were involved in the Food and Cosmetics sector. The second most common type of company cited in the time period worked in the the Devices sector.
Of the companies cited, 17 should take voluntary actions to correct their managing operations (89.5%). Additionally, two companies had to take regulatory and/or administrative actions (10.5%).
The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.
The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.
Company Name | Area of Business | Inspection Date | Issue Cited |
---|---|---|---|
Amcor Rigid Packaging USA, LLC | Devices | 01/12/2023 | Evaluation of suppliers, contractors, etc., requirements |
Amcor Rigid Packaging USA, LLC | Devices | 01/12/2023 | Nonconforming product, Lack of or inadequate procedures |
Amcor Rigid Packaging USA, LLC | Devices | 01/12/2023 | Lack of or inadequate complaint procedures |
Anbar Distributions, LLC | Food and Cosmetics | 08/17/2023 | Very small importer assurances, supplier |
Biscuits & Cookies International | Food and Cosmetics | 08/15/2023 | Supplier approval - document |
Biscuits & Cookies International | Food and Cosmetics | 08/15/2023 | Approved supplier procedures - importer established |
Biscuits & Cookies International | Food and Cosmetics | 08/15/2023 | Supplier verification - establish written procedures |
Biscuits & Cookies International | Food and Cosmetics | 08/15/2023 | Record - English |
Brian Flowers | Drugs | 03/23/2023 | FD-1572, protocol compliance |
Dart Container Corporation | Food and Cosmetics | 08/25/2023 | Hazard analysis written |
Dart Container Corporation | Food and Cosmetics | 08/25/2023 | Evaluation - performance, risk |
Dart Container Corporation | Food and Cosmetics | 08/25/2023 | Verification activity assurance |
Dart Container Corporation | Food and Cosmetics | 08/25/2023 | Verification activity before import, periodically |
Fruit Of The Earth Research Laboratories, Inc. | Drugs | 03/31/2023 | Buildings not maintained in good state of repair |
Inmar Supply Chain Solutions, LLC | Devices | 07/19/2023 | Grounds |
Inmar Supply Chain Solutions, LLC | Devices | 07/19/2023 | Sanitary operations - Plant maintenance |
Inmar Supply Chain Solutions, LLC | Devices | 07/19/2023 | Pest control |
Inmar Supply Chain Solutions, LLC | Devices | 07/19/2023 | Procedures not in writing, fully followed |
Inmar Supply Chain Solutions, LLC | Devices | 07/19/2023 | Sanitation--buildings not clean, free of infestation |
Inmar Supply Chain Solutions, LLC | Devices | 07/19/2023 | Buildings not maintained in good state of repair |
Inmar Supply Chain Solutions, LLC | Devices | 07/19/2023 | Storage under appropriate conditions |
Inmar Supply Chain Solutions, LLC | Devices | 07/19/2023 | Distribution Record Requirements |
Inmar Supply Chain Solutions, LLC | Devices | 07/19/2023 | Salvaging and return to marketplace |
Inmar Supply Chain Solutions, LLC | Devices | 07/19/2023 | Insanitary Conditions (FDCA 501(a)(2)(A)) |
Inmar Supply Chain Solutions, LLC | Drugs | 07/19/2023 | Grounds |
Inmar Supply Chain Solutions, LLC | Drugs | 07/19/2023 | Sanitary operations - Plant maintenance |
Inmar Supply Chain Solutions, LLC | Drugs | 07/19/2023 | Pest control |
Inmar Supply Chain Solutions, LLC | Drugs | 07/19/2023 | Procedures not in writing, fully followed |
Inmar Supply Chain Solutions, LLC | Drugs | 07/19/2023 | Sanitation--buildings not clean, free of infestation |
Inmar Supply Chain Solutions, LLC | Drugs | 07/19/2023 | Buildings not maintained in good state of repair |
Inmar Supply Chain Solutions, LLC | Drugs | 07/19/2023 | Storage under appropriate conditions |
Inmar Supply Chain Solutions, LLC | Drugs | 07/19/2023 | Distribution Record Requirements |
Inmar Supply Chain Solutions, LLC | Drugs | 07/19/2023 | Salvaging and return to marketplace |
Inmar Supply Chain Solutions, LLC | Drugs | 07/19/2023 | Insanitary Conditions (FDCA 501(a)(2)(A)) |
Inmar Supply Chain Solutions, LLC | Food and Cosmetics | 07/19/2023 | Grounds |
Inmar Supply Chain Solutions, LLC | Food and Cosmetics | 07/19/2023 | Sanitary operations - Plant maintenance |
Inmar Supply Chain Solutions, LLC | Food and Cosmetics | 07/19/2023 | Pest control |
Inmar Supply Chain Solutions, LLC | Food and Cosmetics | 07/19/2023 | Procedures not in writing, fully followed |
Inmar Supply Chain Solutions, LLC | Food and Cosmetics | 07/19/2023 | Sanitation--buildings not clean, free of infestation |
Inmar Supply Chain Solutions, LLC | Food and Cosmetics | 07/19/2023 | Buildings not maintained in good state of repair |
Inmar Supply Chain Solutions, LLC | Food and Cosmetics | 07/19/2023 | Storage under appropriate conditions |
Inmar Supply Chain Solutions, LLC | Food and Cosmetics | 07/19/2023 | Distribution Record Requirements |
Inmar Supply Chain Solutions, LLC | Food and Cosmetics | 07/19/2023 | Salvaging and return to marketplace |
Inmar Supply Chain Solutions, LLC | Food and Cosmetics | 07/19/2023 | Insanitary Conditions (FDCA 501(a)(2)(A)) |
Lucid Wellness, LLC | Food and Cosmetics | 02/17/2023 | Quality control - quality, dietary supplement |
Lucid Wellness, LLC | Food and Cosmetics | 02/17/2023 | Reserve sample - collect, hold |
Lucid Wellness, LLC | Food and Cosmetics | 02/17/2023 | Written procedures - holding |
Lucid Wellness, LLC | Food and Cosmetics | 02/17/2023 | Written procedures - returned dietary supplement |
Lucid Wellness, LLC | Food and Cosmetics | 02/17/2023 | Written procedures - product complaint |
Mannatech Incorporated | Food and Cosmetics | 09/13/2023 | Develop FSVP |
Marriott International, Inc. | Food and Cosmetics | 11/13/2023 | Identification - entry |
Marriott International, Inc. | Food and Cosmetics | 11/13/2023 | Regulatory oversight |
Mid-States Distributing, LLC | Veterinary | 09/11/2023 | Document review entity's hazard analysis |
Mid-States Distributing, LLC | Veterinary | 09/11/2023 | Evaluation - performance, risk |
Mid-States Distributing, LLC | Veterinary | 09/11/2023 | Verification activity before import, periodically |
Mission Produce, Inc. | Food and Cosmetics | 06/06/2023 | Sanitary facilities and controls |
Mtek Group, LLC | Food and Cosmetics | 09/27/2023 | Approved supplier procedures - importer established |
Nelson Enviromental Technologies, Inc. | Devices | 10/10/2023 | Purchasing controls, Lack of or inadequate procedures |
Nurse Assist, LLC | Devices | 09/21/2023 | Individual Report of Malfunction |
Nurse Assist, LLC | Devices | 09/21/2023 | Training - Lack of or inadequate procedures |
Nurse Assist, LLC | Devices | 09/21/2023 | Design Validation - Risk analysis not performed/inadequate |
Nurse Assist, LLC | Devices | 09/21/2023 | Purchasing controls, Lack of or inadequate procedures |
Nurse Assist, LLC | Devices | 09/21/2023 | Contamination control, Lack of or inadequate procedures |
Nurse Assist, LLC | Devices | 09/21/2023 | Maintenance schedule, Lack of or inadequate schedule |
Nurse Assist, LLC | Devices | 09/21/2023 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
Nurse Assist, LLC | Devices | 09/21/2023 | Lack of or inadequate process validation |
Nurse Assist, LLC | Devices | 09/21/2023 | Lack/Inad procedure-Monitoring/Control of Validated Proces |
Nurse Assist, LLC | Devices | 09/21/2023 | Nonconforming product, Lack of or inadequate procedures |
Nurse Assist, LLC | Devices | 09/21/2023 | Lack of or inadequate procedures |
Premier Produce Services | Food and Cosmetics | 05/02/2023 | Supplier approval - document |
Premier Produce Services | Food and Cosmetics | 05/02/2023 | Onsite audit |
Pulido Associates, Inc. | Food and Cosmetics | 04/20/2023 | Toxic chemicals - Identified, held, stored |
Pulido Associates, Inc. | Food and Cosmetics | 04/20/2023 | Hazard analysis - Conducted |
Pulido Associates, Inc. | Food and Cosmetics | 04/20/2023 | Sanitation preventive controls - Implement |
Renfro Foods, Inc. | Food and Cosmetics | 08/31/2023 | Process deviation |
Renfro Foods, Inc. | Food and Cosmetics | 08/31/2023 | Qualifications of individuals |
Talia Foods, LLC | Food and Cosmetics | 09/15/2023 | Develop FSVP |