Drug factory · FDA FEI 2220525

Hikma Pharmaceuticals USA Inc.

2 Esterbrook Lane, Cherry Hill, NJ, United States

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Jun 12, 2024 inspection

• Procedures for non-sterile drug products 21 CFR 211.113(a)
  Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established and followed.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.

Jun 14, 2013 inspection

• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
• Investigations of discrepancies, failures 21 CFR 211.192
  There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not fully followed.
• Calibration/Inspection/Checking not done 21 CFR 211.68(a)
  Routine calibration of equipment is not performed according to a written program designed to assure proper performance.

Apr 13, 2011 inspection

• Correct labels during finishing operations 21 CFR 211.134(a)
  Packaged and labeled products are not examined during finishing operations to provide assurance that containers and packages in the lot have the correct label.
• Scientifically sound laboratory controls 21 CFR 211.160(b)
  Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.

Registered with FDA for: analysis; api manufacture; label; manufacture; pack; relabel; repack; salvage.