Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
Dr. Namandjé N. Bumpus Principal Deputy Commissioner - FDA | Official Website
This is unchanged from the number of companies cited in the previous year.
Of the 48 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 Devices sector.
Of the companies cited, 16 should take voluntary actions to correct their managing operations (88.9%). Additionally, one company had to take regulatory and/or administrative actions (5.6%).
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 |
---|---|---|---|
Atlas Medical Holdings, Inc. | Biologics | 09/21/2023 | All core requirements covered in program |
Atlas Medical Holdings, Inc. | Biologics | 09/21/2023 | Evaluation--microorganisms, damage |
Blue Baja, LLC | Food and Cosmetics | 03/03/2023 | Written procedures - personnel qualifications |
Blue Baja, LLC | Food and Cosmetics | 03/03/2023 | Written procedures - holding |
Blue Baja, LLC | Food and Cosmetics | 03/03/2023 | Written procedures - returned dietary supplement |
Blue Baja, LLC | Food and Cosmetics | 03/03/2023 | Written procedures - product complaint |
C. T. Grocers, LLC | Food and Cosmetics | 03/01/2023 | Hazard analysis written |
C. T. Grocers, LLC | Food and Cosmetics | 03/01/2023 | Verification activity before import, periodically |
Dulces La Mejor, LLC | Food and Cosmetics | 04/21/2023 | Hazard analysis written |
Dulces La Mejor, LLC | Food and Cosmetics | 04/21/2023 | Hazard analysis biological, chemical, physical |
ErgoMed, Inc. | Devices | 12/06/2023 | Label to bear a unique device identifier |
ErgoMed, Inc. | Devices | 12/06/2023 | Complaints |
ErgoMed, Inc. | Devices | 12/06/2023 | Devices subject to device identification GUDID data submission requirements. |
Footprint Medical, Inc. | Devices | 06/14/2023 | Personnel |
Footprint Medical, Inc. | Devices | 06/14/2023 | Design verification - Lack of or inadequate procedures |
Footprint Medical, Inc. | Devices | 06/14/2023 | Incorrect translation to production specifications |
Footprint Medical, Inc. | Devices | 06/14/2023 | Production processes |
Footprint Medical, Inc. | Devices | 06/14/2023 | Software validation for automated processes |
Footprint Medical, Inc. | Devices | 06/14/2023 | Lack of or inadequate process validation |
Footprint Medical, Inc. | Devices | 06/14/2023 | Lack of or inadequate procedures |
Footprint Medical, Inc. | Devices | 06/14/2023 | Statistical techniques - Lack of or inadequate procedures |
Germaine Laboratories, Inc. | Devices | 09/27/2023 | Quality audits - Lack of or inadequate procedures |
Germaine Laboratories, Inc. | Devices | 09/27/2023 | Documentation |
Germaine Laboratories, Inc. | Devices | 09/27/2023 | Lack of or inadequate procedures |
Germaine Laboratories, Inc. | Devices | 09/27/2023 | DHR content |
Germaine Laboratories, Inc. | Devices | 09/27/2023 | Statistical techniques - Lack of or inadequate procedures |
LA Aldea Distributors, Inc. | Food and Cosmetics | 08/11/2023 | Develop FSVP |
Magaya Foods | Food and Cosmetics | 03/09/2023 | Develop FSVP |
Mega PG Distributions | Food and Cosmetics | 04/11/2023 | Develop FSVP |
Mesquite Gourmet, LLC | Food and Cosmetics | 07/20/2023 | Develop FSVP |
Mesquite Gourmet, LLC | Food and Cosmetics | 07/20/2023 | Identification - entry |
NBF Distributions, Inc. | Food and Cosmetics | 01/30/2023 | Develop FSVP |
Texas Fertility Center | Biologics | 06/21/2023 | Risk factors, clinical evidence |
Tiller MIND BODY, Inc. | Devices | 07/13/2023 | Lack of or inadequate final acceptance procedures |
Tiller MIND BODY, Inc. | Devices | 07/13/2023 | Lack of or inadequate DHR procedures |
Tiller MIND BODY, Inc. | Devices | 07/13/2023 | Lack of or inadequate complaint procedures |
UT Health San Antonio Reproductive Health and Fertility Center | Biologics | 01/06/2023 | Determination based on screening and testing |
Ultra International Distributors | Food and Cosmetics | 12/04/2023 | Develop FSVP |
Ultra International Distributors | Food and Cosmetics | 12/04/2023 | Verification activity - appropriate |
Ultra International Distributors | Food and Cosmetics | 12/04/2023 | Identification - entry |
Ultra International Distributors | Food and Cosmetics | 12/04/2023 | Record - translate to English |
World Green Nutrition, Inc. | Food and Cosmetics | 05/30/2023 | Develop FSVP |
XENEX Disinfection Services, Inc. | Devices | 10/31/2023 | Quality audits - Lack of or inadequate procedures |
XENEX Disinfection Services, Inc. | Devices | 10/31/2023 | Design changes - Lack of or Inadequate Procedures |
XENEX Disinfection Services, Inc. | Devices | 10/31/2023 | Software validation for automated processes |
XENEX Disinfection Services, Inc. | Devices | 10/31/2023 | Lack of or inadequate procedures |
XENEX Disinfection Services, Inc. | Devices | 10/31/2023 | DMR - not or inadequately maintained |
XENEX Disinfection Services, Inc. | Devices | 10/31/2023 | Lack of or inadequate complaint procedures |