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 unchanged from the number of companies cited in the previous quarter.
The citations in the county include:
- Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
- 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.
- The procedures for the annual quality standards record evaluation are deficient in that they do not address a review of a representative number of approved batches.
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 |
|---|---|---|---|
| SUCO, Inc. | Drugs | 02/25/2024 | Equipment Design, Size and Location |
| SUCO, Inc. | Drugs | 02/25/2024 | Absence of Written Procedures |
| SUCO, Inc. | Drugs | 02/25/2024 | Representative Number of Batches for Annual Review |
| SUCO, Inc. | Drugs | 02/25/2024 | Batch production and Batch Control Record Requirements |
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