Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
Mark Raza Principal Deputy Chief Counsel - FDA | Official Website
This is a 5.9% increase over the number of companies cited in the previous year.
Of the 53 citations issued, the most common citation was 'You did not develop an FSVP'.
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 Drugs sector.
Of the companies cited, 16 should take voluntary actions to correct their managing operations (88.9%). Additionally, two companies had to take regulatory and/or administrative actions (11.1%).
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 |
---|---|---|---|
ARG Laboratories, Inc. | Drugs | 09/20/2023 | Lack of quality control unit |
ARG Laboratories, Inc. | Drugs | 09/20/2023 | Reports of Analysis (Components) |
ARG Laboratories, Inc. | Drugs | 09/20/2023 | Retest of approved components/containers/closures |
ARG Laboratories, Inc. | Drugs | 09/20/2023 | Control procedures to monitor and validate performance |
ARG Laboratories, Inc. | Drugs | 09/20/2023 | Expiration date lacking |
ARG Laboratories, Inc. | Drugs | 09/20/2023 | Scientifically sound laboratory controls |
ARG Laboratories, Inc. | Drugs | 09/20/2023 | Failing drug products not rejected |
Anesthetic Gas Reclamation, Inc. | Devices | 05/04/2023 | Quality audits - auditor independence |
Anesthetic Gas Reclamation, Inc. | Devices | 05/04/2023 | Procedures not adequately established or maintained |
Anesthetic Gas Reclamation, Inc. | Devices | 05/04/2023 | Purchasing controls, Lack of or inadequate procedures |
Anesthetic Gas Reclamation, Inc. | Devices | 05/04/2023 | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
Anesthetic Gas Reclamation, Inc. | Devices | 05/04/2023 | Lack of or inadequate final acceptance procedures |
Anesthetic Gas Reclamation, Inc. | Devices | 05/04/2023 | Lack of or inadequate complaint procedures |
Beverage King, LLC | Food and Cosmetics | 07/13/2023 | Manufacturing, processing, packing, holding - Controls |
Beverage King, LLC | Food and Cosmetics | 07/13/2023 | All hazards not considered |
Beverage King, LLC | Food and Cosmetics | 07/13/2023 | Calibration, testing - no records |
Beverage King, LLC | Food and Cosmetics | 07/13/2023 | Records - actual values |
Buda Juice, LLC | Food and Cosmetics | 11/14/2023 | HACCP plan - monitoring procedures - none listed |
Buda Juice, LLC | Food and Cosmetics | 11/14/2023 | HACCP plan - corrective action plan not included |
Colgin, Inc. | Drugs | 09/21/2023 | Procedures not in writing, fully followed |
Colgin, Inc. | Drugs | 09/21/2023 | Cleaning / Sanitizing / Maintenance |
Colgin, Inc. | Drugs | 09/21/2023 | Identity Testing of Each Component |
Colgin, Inc. | Drugs | 09/21/2023 | Actual vs. theoretical yields not determined |
Colgin, Inc. | Drugs | 09/21/2023 | Testing and release for distribution |
Creative Liquids, LLC | Food and Cosmetics | 07/20/2023 | Instruments - calibration |
El Gordo Spices, LLC | Food and Cosmetics | 03/22/2023 | Hazard analysis - Conducted |
Fertility and Advanced Reproductive Medicine at UTSW | Biologics | 12/13/2023 | Donor testing not negative for CD agents |
Fertility and Advanced Reproductive Medicine at UTSW | Biologics | 12/13/2023 | Documentation--determination, by whom, date |
Fertility and Advanced Reproductive Medicine at UTSW | Biologics | 12/13/2023 | Risk factors, clinical evidence |
Fertility and Advanced Reproductive Medicine at UTSW | Biologics | 12/13/2023 | Eligibility not required--warning labels |
Grain Market, LLC | Food and Cosmetics | 07/10/2023 | Hazard analysis written |
Grain Market, LLC | Food and Cosmetics | 07/10/2023 | Evaluation - performance, risk |
Grain Market, LLC | Food and Cosmetics | 07/10/2023 | Approved supplier procedures - importer established |
Grain Market, LLC | Food and Cosmetics | 07/10/2023 | Verification activity frequency |
Grain Market, LLC | Food and Cosmetics | 07/10/2023 | Verification activity - appropriate |
Grain Market, LLC | Food and Cosmetics | 07/10/2023 | Verification activity before import, periodically |
Hiland Dairy Foods Company, LLC | Food and Cosmetics | 08/04/2023 | Sanitary operations - Plant sanitation |
JMD, LLC | Food and Cosmetics | 08/07/2023 | Qualifications of individuals |
JMD, LLC | Food and Cosmetics | 08/07/2023 | Pest control |
JMD, LLC | Food and Cosmetics | 08/07/2023 | Record availability |
Parvez Mantry | Drugs | 11/14/2023 | FD-1572, protocol compliance |
Post Oak Innovations, Inc. | Devices | 10/13/2023 | Document change records, maintained. |
Post Oak Innovations, Inc. | Devices | 10/13/2023 | Acceptable supplier records, inadequate records |
Post Oak Innovations, Inc. | Devices | 10/13/2023 | Lack of or inadequate procedures |
RP Foods, LLC | Food and Cosmetics | 07/06/2023 | Develop FSVP |
SouQ El Sudan, Inc. | Food and Cosmetics | 09/08/2023 | Develop FSVP |
Third Coast Marketing Holdings, LP | Food and Cosmetics | 08/03/2023 | Written procedures - quality control operations |
Third Coast Marketing Holdings, LP | Food and Cosmetics | 08/03/2023 | Written procedures - holding |
Third Coast Marketing Holdings, LP | Food and Cosmetics | 08/03/2023 | Written procedures - returned dietary supplement |
Third Coast Marketing Holdings, LP | Food and Cosmetics | 08/03/2023 | Written procedures - product complaint |
Third Coast Marketing Holdings, LP | Food and Cosmetics | 08/03/2023 | Quality control operations - packaging, labeling; approving, rejecting |
Unifi Aviation, LLC | Food and Cosmetics | 01/25/2023 | Handling to avoid contamination |
Yi Group, Inc. | Food and Cosmetics | 09/15/2023 | Develop FSVP |