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 30% decrease from the number of companies cited in the previous month.
Of the 23 citations issued, the most common citation was 'You did not document that you conducted an evaluation or reviewed and assessed an evaluation conducted by another entity to determine a foreign supplier's performance and the risk posed by a food'.
Most of the companies cited were involved in the Food and Cosmetics sector.
Of the companies cited, five should take voluntary actions to correct their managing operations (71.4%). 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.
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 |
---|---|---|---|
Ami Caribbean | Food and Cosmetics | 02/28/2025 | Evaluation - performance, risk |
Ami Caribbean | Food and Cosmetics | 02/28/2025 | Reevaluate - 3 years |
Ami Caribbean | Food and Cosmetics | 02/28/2025 | Audit - food safety regulation, plan |
Capitol Food Company | Food and Cosmetics | 02/03/2025 | Sanitary operations - Plant sanitation |
Capitol Food Company | Food and Cosmetics | 02/03/2025 | Raw materials - Allergen identification |
Capitol Food Company | Food and Cosmetics | 02/03/2025 | Manufacturing, processing, packing, holding - Controls |
La Fiesta Food Products | Food and Cosmetics | 02/20/2025 | Hazard analysis - Identification of hazard |
Medical Chemical Corporation | Drugs | 02/18/2025 | Component identity verification |
Medical Chemical Corporation | Drugs | 02/18/2025 | Component written specification |
Medical Chemical Corporation | Drugs | 02/18/2025 | Establish reliability of supplier's C of A |
Medical Chemical Corporation | Drugs | 02/18/2025 | Absence of Written Procedures |
Medical Chemical Corporation | Drugs | 02/18/2025 | Test methods |
Medical Chemical Corporation | Drugs | 02/18/2025 | Batch production and Batch Control Record Requirements |
Medical Chemical Corporation | Drugs | 02/18/2025 | Extent of discrepancy, failure investigations |
Medical Chemical Corporation | Drugs | 02/18/2025 | Complete Test Data |
Pacific American Fish Company | Food and Cosmetics | 02/27/2025 | HACCP plan implementation |
Pacific American Fish Company | Food and Cosmetics | 02/27/2025 | Corrective action per predetermined plan |
Pacific American Fish Company | Food and Cosmetics | 02/27/2025 | Sanitation monitoring |
R. M. Produce, Corp. | Food and Cosmetics | 02/20/2025 | Develop FSVP |
R. M. Produce, Corp. | Food and Cosmetics | 02/20/2025 | Hazard analysis written |
R. M. Produce, Corp. | Food and Cosmetics | 02/20/2025 | Evaluation - performance, risk |
Umina Brothers, Inc. | Food and Cosmetics | 02/25/2025 | Plant construction and design |
Umina Brothers, Inc. | Food and Cosmetics | 02/25/2025 | Storage and Distribution |