Catalent Pharma Solutions, LLC – FDA 483, Mar 25, 2016

This FDA Form 483 details multiple observations from an inspection, indicating significant deficiencies in the facility's quality system and manufacturing controls.

A primary issue is the failure to thoroughly review unexplained discrepancies and out-of-specification results. Specifically, SOP OTS-QA-0038 for investigations was not followed, with an investigation opened 11 days late instead of within the required (b)(4) timeframe. Investigations for Valproic Acid Capsules, USP 250 mg (PR #s 408449, 414181, 478203, 488400, 500065, 513500) regarding multiple complaints of blue spots on capsules since 2013 (lots 1291888, 1391388, 1391390, 1460931) lacked detailed root cause analysis. Potential causes like chipped encapsulation machine paint and operator glove use were not assessed. Additionally, retain samples for lot #1291888 were not fully evaluated before discard. The conclusion that issues were not manufacturing-related was unsubstantiated.

Another observation notes that Investigation PR# 447113, concerning an out-of-range refrigerator (b)(4) 1745787, failed to