New Jersey Drugmaker Gets FDA Ding Over Quality Control Problems

Bloomberg Law tracks recent federal government administrative actions and warnings directed toward pharmaceutical and life sciences entities.

Health Pharma USA LLC

• Issuing Office: Food and Drug Administration, Division of Pharmaceutical Quality Operations
• Recipient: Hasmukh Patel (chief executive officer and chief operating officer)
• Date: Dec. 18 (posted Jan. 14)
• Inspection of facility in Rahway, N.J., May 13-June 3

Alleged Infractions

• Quality control unit lacked adequate written procedures for many functions, including review and approval of executed batch records, batch release, investigation of out-of-specification results, cleaning, equipment qualification, stability testing, gowning, and sample control.
• Quality control unit often failed ...