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 16.7% increase over the number of companies cited in the previous quarter.
The citations in the county include:
- You did not provide FDA with information on the scheduled process for a new acidified food before packing the food.
- Each container is not marked with an identifying code specifying the establishment where the product was packed.
- The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Most of the companies cited were involved in the Food and Cosmetics sector.
Of the companies cited, six should take voluntary actions to correct their managing operations (85.7%). Additionally, one company had to take regulatory and/or administrative actions (14.3%).
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 |
---|---|---|---|
DPI Specialty Foods West, Inc. | Food and Cosmetics | 10/17/2023 | Develop FSVP |
Maple Lane Bakery, Inc. | Food and Cosmetics | 10/27/2023 | Personnel |
Maple Lane Bakery, Inc. | Food and Cosmetics | 10/27/2023 | Plant construction and design |
Myojo USA, Inc. | Food and Cosmetics | 11/01/2023 | Process filing |
Myojo USA, Inc. | Food and Cosmetics | 11/01/2023 | Code - required elements |
San Bernardino International Airport | Food and Cosmetics | 10/25/2023 | Prevention of the spread of communicable diseases |
San Bernardino International Airport | Food and Cosmetics | 10/25/2023 | Prevention of contamination |
Sky Chefs, Inc. | Food and Cosmetics | 10/27/2023 | Manufacturing, processing, packing, holding - Controls |
Table de France, Inc. | Food and Cosmetics | 10/20/2023 | Sanitation of non-food-contact surfaces - Manner and frequency |
Table de France, Inc. | Food and Cosmetics | 10/20/2023 | Manufacturing, processing, packing, holding - Controls |
Table de France, Inc. | Food and Cosmetics | 10/20/2023 | Process control - Foreign objects |
Universal Packaging Systems, Inc. | Drugs | 11/17/2023 | Procedures not in writing, fully followed |
Universal Packaging Systems, Inc. | Drugs | 11/17/2023 | Mfg / Processing Operations Area |
Universal Packaging Systems, Inc. | Drugs | 11/17/2023 | Written procedures not established/followed |
Universal Packaging Systems, Inc. | Drugs | 11/17/2023 | Computer control of master formula records |
Universal Packaging Systems, Inc. | Drugs | 11/17/2023 | Absence of Written Procedures |
Universal Packaging Systems, Inc. | Drugs | 11/17/2023 | Following/documenting laboratory controls |
Universal Packaging Systems, Inc. | Drugs | 11/17/2023 | Scientifically sound laboratory controls |
Universal Packaging Systems, Inc. | Drugs | 11/17/2023 | Extent of discrepancy, failure investigations |