Keystone Laboratories, Inc. – FDA 483, Feb 5, 2016

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from February 1-5, 2016, Keystone Laboratories Inc. of Memphis, TN, received a Form FDA 483 outlining significant observations. The inspection revealed critical deficiencies in the company's manufacturing and quality control processes. The primary issues observed included the release of drug products without adequate laboratory testing, or in some instances, with positive microbial contamination (Staph aureus) prior to distribution. Several batch records indicated product release without completed microbiological testing or with discrepancies in testing documentation and approval dates. This particular observation was noted as a repeat finding from previous inspections in 2014 and 2015, indicating a persistent problem. Furthermore, the FDA investigators found that Keystone Laboratories' written stability program for drug products was deficient. Specifically, the test methods used to assess product stability had not been validated, and the firm failed to test for impurities or degradants. This was also a recurring observation from multiple prior inspections dating back to 2012. Compounding this, the company was not adhering to its own established written stability testing program, with numerous stability records showing incomplete testing at required intervals as per their standard operating procedures. These observations highlight a need for Keystone Laboratories Inc. to implement comprehensive corrective actions to ensure drug product quality, patient safety, and compliance with federal regulations.