FDA 483 - Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. - March 04, 2013

The FDA Form 483 details numerous violations at a drug manufacturing facility. Key issues include a failure to thoroughly investigate unexplained discrepancies, even for distributed batches, with specific examples related to Diazepam API impurity testing and retained samples from 2009-2012. An investigation into Acetaldehyde formation during shelf life was incomplete.

Supplier qualification is deficient, with no inspections of Phenol raw material suppliers for ATNAA, and a general failure to inspect raw material suppliers for human drug products per SOP QLA-COM-00010.

Manufacturing and quality control problems are extensive. Atropen Lot 2FP298 had unaccounted overage of injectors. Foreign material was found in Atropen lot # 2MP470. Procedures to prevent microbiological contamination of sterile drug products are not established or followed, including employee gowning (SOP -PRO-FIL-00002-SL) and glove changes. Media fill simulations lack worst-case scenarios, and fluorescent light fixtures in Class 100 areas are excluded from sanitization procedures (SOP-PRO-FIL-00047-SL). Repeated high particle excursions occur in the Epi-Pen filling suite.

Material reconciliation is inaccurate for Diazepam batch records. The facility failed to use the appropriate sampling plan (ANSI/ASQ A1-4-2008) for secondary and tertiary packaging. Production and process control procedures