Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
Leah Hunter Commissioner for External Affairs (OEA) within the Office of the Commissioner at the U.S. Food and Drug Administration | Official Website
This is a 100% increase over the number of companies cited in the previous month.
The citations in the county include:
- You did not identify and hold cleaning compounds, sanitizing agents, pesticides, pesticide chemicals, or other toxic materials in a manner that protects against contamination of components, dietary supplements, or contact surfaces.
- Your hand-washing facilities are not adequate and do not furnish running water at a suitable temperature.
- You did not establish component specifications for strength and composition.
All 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 (83.3%). Additionally, one company had to take regulatory and/or administrative actions (16.7%).
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 |
---|---|---|---|
Alfa Vitamins Laboratories, Inc. | Food and Cosmetics | 07/17/2024 | Cleaning compounds and toxic materials - holding |
Alfa Vitamins Laboratories, Inc. | Food and Cosmetics | 07/17/2024 | Hand-washing facilities |
Alfa Vitamins Laboratories, Inc. | Food and Cosmetics | 07/17/2024 | Specifications-component purity, strength, composition |
Alfa Vitamins Laboratories, Inc. | Food and Cosmetics | 07/17/2024 | Specifications - identity, purity, strength, composition |
Alfa Vitamins Laboratories, Inc. | Food and Cosmetics | 07/17/2024 | Master manufacturing record - each batch |
Alfa Vitamins Laboratories, Inc. | Food and Cosmetics | 07/17/2024 | Packaging description, representative label |
Alfa Vitamins Laboratories, Inc. | Food and Cosmetics | 07/17/2024 | Written procedures - laboratory operations |
Alfa Vitamins Laboratories, Inc. | Food and Cosmetics | 07/17/2024 | Hold - temperature, humidity, light |
Cubanita Frozen Foods Corporation | Food and Cosmetics | 07/12/2024 | Personnel |
Cubanita Frozen Foods Corporation | Food and Cosmetics | 07/12/2024 | Pest control |
Cubanita Frozen Foods Corporation | Food and Cosmetics | 07/12/2024 | Manufacturing, processing, packing, holding - Controls |
Cubanita Frozen Foods Corporation | Food and Cosmetics | 07/12/2024 | Food safety plan |
Interfood Trading Group, Inc. | Food and Cosmetics | 07/09/2024 | Develop FSVP |
Interfood Trading Group, Inc. | Food and Cosmetics | 07/09/2024 | Record - available |
LEASA Industries Company, Inc. | Food and Cosmetics | 07/26/2024 | Equip & tools - cleanability |
LEASA Industries Company, Inc. | Food and Cosmetics | 07/26/2024 | Written environmental monitoring plan |
Newpharma, Inc. | Food and Cosmetics | 07/01/2024 | Quality control - production, process control |
Newpharma, Inc. | Food and Cosmetics | 07/01/2024 | Quality control - reject; specification not met |
Newpharma, Inc. | Food and Cosmetics | 07/01/2024 | Written procedures - packaging |
Ocho Rios-Miami, Inc. | Food and Cosmetics | 07/16/2024 | Hazard analysis |
Ocho Rios-Miami, Inc. | Food and Cosmetics | 07/16/2024 | HACCP plan implementation |
Ocho Rios-Miami, Inc. | Food and Cosmetics | 07/16/2024 | Food safety hazards |
Ocho Rios-Miami, Inc. | Food and Cosmetics | 07/16/2024 | Verification - record review - frequency |