Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website
Hilary Marston, M.D., M.P.H. Chief Medical Officer (CMO) of the FDA | Official Website
This is a 20% decrease from the number of companies cited in the previous year.
The citations in the county include:
- During a field examination of food products at your facility the following were observed:.
- Your plant did not have adequate sanitary facilities and accommodations.
- You did not identify a process preventive control for a hazard when one was needed.
Most of the companies cited were involved in the Food and Cosmetics sector.
Of the companies cited, three should take voluntary actions to correct their managing operations (75%). Additionally, one company had to take regulatory and/or administrative actions (25%).
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.
According to its website, 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.
Company Name | Area of Business | Inspection Date | Issue Cited |
---|---|---|---|
Charles River Laboratories, Inc. | Drugs | 01/04/2024 | Absence of Written Procedures |
Charles River Laboratories, Inc. | Drugs | 01/04/2024 | Investigations of discrepancies, failures |
Mompops | Food and Cosmetics | 04/11/2024 | Sanitary facilities and controls |
Mompops | Food and Cosmetics | 04/11/2024 | Process preventive controls - Identify (Written) |
P & L Bean Sprout Farm | Food and Cosmetics | 03/12/2024 | Food Field Exam |
US Food Manufacturing | Food and Cosmetics | 06/14/2024 | Specifications - component identity |
US Food Manufacturing | Food and Cosmetics | 06/14/2024 | Specifications-component purity, strength, composition |
US Food Manufacturing | Food and Cosmetics | 06/14/2024 | Specifications - identity, purity, strength, composition |
US Food Manufacturing | Food and Cosmetics | 06/14/2024 | Re-confirm certificate of analysis |
US Food Manufacturing | Food and Cosmetics | 06/14/2024 | Specifications met - verify; finished batch |
US Food Manufacturing | Food and Cosmetics | 06/14/2024 | Instructions; specifications; packaged, labeled |
US Food Manufacturing | Food and Cosmetics | 06/14/2024 | Batch record - date, time; maintenance |
US Food Manufacturing | Food and Cosmetics | 06/14/2024 | Batch record - yield |
US Food Manufacturing | Food and Cosmetics | 06/14/2024 | Batch record - identifier; labels |