FDA 483 - Penta International Corp - February 16, 2024

An FDA inspection conducted from February 12-16, 2024, at Penta Manufacturing Company, an API Repacker/Relabeler in West Caldwell, NJ, identified significant deviations from regulatory requirements for Active Pharmaceutical Ingredients (APIs). The firm received an FDA Form 483 detailing eight observations related to quality control and operational practices.

Key issues included the inadequate cleaning and sanitization of shared utensils used for APIs, posing a contamination risk. Certificates of Analysis issued by the company for repacked products lacked essential information about the analyzing laboratory and original manufacturers. Furthermore, Penta Manufacturing failed to perform stability studies for repacked APIs in market-simulating containers and assigned unsupported retest/expiration dates that often exceeded original manufacturer specifications.

Procedural shortcomings were prominent: there was an absence of master production instructions for API products, a lack of documented procedures for a quality unit and its responsibilities (such as product release and complaint resolution), and missing documented procedures for material sampling, testing, and laboratory data management. The firm also lacked specific test methods for liquid APIs and corresponding employee training records. Critically, Penta Manufacturing did not conduct identity testing for each API batch, including specific tests for high-risk products like Glycerin USP, and had no supplier qualification program.

To achieve compliance with API Good Manufacturing Practices, Penta Manufacturing Company must implement comprehensive corrective actions. These actions should include developing robust quality systems, establishing proper cleaning and testing protocols, conducting necessary stability studies, and ensuring thorough documentation and effective quality unit oversight.