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New Jersey Drugmaker Gets FDA Ding Over Quality Control Problems

Jan. 14, 2020, 7:04 PM

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...
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