Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
Kimberlee Trzeciak Deputy Commissioner for Policy, Legislation, and International Affairs of FDA | Official Website
This is a 100% increase over the number of companies cited in the previous quarter.
The citations in the county include:
- The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
- Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.
- Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Both companies cited were involved in either Drugs or Food and Cosmetics 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.
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 |
---|---|---|---|
SCT Corporation | Food and Cosmetics | 06/07/2024 | Pest control |
SCT Corporation | Food and Cosmetics | 06/07/2024 | Sanitation of food-contact surfaces - Frequency |
SCT Corporation | Food and Cosmetics | 06/07/2024 | Raw materials - Allergen identification |
Warner Graham, LLP | Drugs | 05/21/2024 | Procedures not in writing, fully followed |
Warner Graham, LLP | Drugs | 05/21/2024 | Cleaning SOPs/instructions |
Warner Graham, LLP | Drugs | 05/21/2024 | Absence of Written Procedures |
Warner Graham, LLP | Drugs | 05/21/2024 | Procedures for non-sterile drug products |
Warner Graham, LLP | Drugs | 05/21/2024 | Lack of written stability program |
Warner Graham, LLP | Drugs | 05/21/2024 | Complete instructions, procedures, specifications et. al. |