FDA WARNING_LETTER - Corepharma LLC - January 20, 2010

An FDA inspection of CorePharma, LLC's pharmaceutical manufacturing facility in Middlesex, New Jersey, from November 2009 to January 2010, identified significant Current Good Manufacturing Practice (CGMP) violations under 21 CFR Parts 210 and 211, rendering drug products adulterated. The firm's February 2010 response was deemed inadequate. Key violations included failure to reject drug products not meeting specifications (e.g., Benzphetamine HCl tablets with coating defects), inadequate investigation of batch failures and Out-of-Specification (OOS) results without extending investigations or determining root causes (e.g., Pilocarpine HCl thickness, Pyridostigmine Bromide black spots, Ropinirole HCl coating defects, delayed action on crushed tablets). The Quality Control Unit (QCU) failed to follow written procedures, such as assigning target completion dates for corrective actions, a repeat observation. The firm also failed to establish procedures to monitor and validate manufacturing processes and reject non-conforming in-process material (e.g., Ursodiol capsule fill weight/dissolution, Ropinirole HCl coating issues). Additionally, CorePharma failed to adhere to its stability testing program and provide adequate systems to control contaminants during production, as evidenced by manufacturing near an open construction area. Repeat observations and concerns about the QCU's effectiveness were highlighted. CorePharma must promptly correct these violations, provide a written response within fifteen working days detailing corrective actions, and address recurrence prevention. Failure to comply may result in legal action, including seizure and injunction, and impact approvals for export certificates or pending drug applications.