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 an increase over the number of companies cited in the previous quarter.
The citations in the county include:
- Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
- Inspection of the packaging and labeling facilities immediately before use is not done to assure that all drug products have been removed from previous operations.
- Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
The company cited should take a voluntary action to correct its 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.
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 |
|---|---|---|---|
| Revlon Group Holdings, LLC | Drugs | 01/12/2024 | Cleaning / Sanitizing / Maintenance |
| Revlon Group Holdings, LLC | Drugs | 01/12/2024 | Packaging line inspection before use |
| Revlon Group Holdings, LLC | Drugs | 01/12/2024 | Scientifically sound laboratory controls |
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