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
- 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...