James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website
James “Jim” Sigg FDA's Deputy Commissioner for Operations and Chief Operating Officer | Official Website
This is unchanged from the number of companies cited in the previous quarter.
The citations in the county include:
- You did not identify an allergen preventive control for a hazard when one was needed.
- You did not have training records for your preventive controls qualified individual.
- You did not establish a written supply-chain program.
The companies cited were involved in either Food and Cosmetics or Drugs sectors.
Both companies cited should take voluntary actions to correct their managing operations.
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 |
---|---|---|---|
Bella Brands, LLC | Food and Cosmetics | 03/17/2025 | Allergen preventive controls - Identify (Written) |
Bella Brands, LLC | Food and Cosmetics | 03/17/2025 | PCQI training records |
Bella Brands, LLC | Food and Cosmetics | 03/17/2025 | Supply-chain program - Establish |
Nitro Quimica Corporation | Drugs | 02/21/2025 | Procedures not in writing, fully followed |
Nitro Quimica Corporation | Drugs | 02/21/2025 | Equipment Design, Size and Location |
Nitro Quimica Corporation | Drugs | 02/21/2025 | Written procedures not established/followed |
Nitro Quimica Corporation | Drugs | 02/21/2025 | Reprocessing procedures not written or followed |
Nitro Quimica Corporation | Drugs | 02/21/2025 | Storage under appropriate conditions |