Drug factory · FDA FEI 1510690

Hikma Pharmaceuticals USA Inc.

1809 Wilson Road, Columbus, OH, 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.

Apr 18, 2018 inspection

• Label storage access limited to authorized personnel 21 CFR 211.122(d)
  Access to the storage area for labels and labeling materials is not limited to authorized personnel.
• Label storage access limited to authorized personnel 21 CFR 211.122(d)
  Access to the storage area for labels and labeling materials is not limited to authorized personnel.
• 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.
• 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 26, 2014 inspection

• Incomplete periodic safety report 21 CFR 314.80(c)(2)(ii)(A)
  Not all periodic reports contained a narrative summary and analysis of the information in the report and an analysis of the post marketing 15-day Alert reports submitted during the reporting interval.
• Incomplete periodic safety report 21 CFR 314.80(c)(2)(ii)(A)
  Not all periodic reports contained a narrative summary and analysis of the information in the report and an analysis of the post marketing 15-day Alert reports submitted during the reporting interval.
• Summary 21 CFR 314.81(b)(2)(i)
  An annual report did not include a brief summary of significant new information from the previous year that might affect the safety, effectiveness, or labeling of the drug product.
• Summary 21 CFR 314.81(b)(2)(i)
  An annual report did not include a brief summary of significant new information from the previous year that might affect the safety, effectiveness, or labeling of the drug product.

Jan 20, 2011 inspection

• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the manufacture of a drug product lack the training required to perform their assigned functions.
• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the manufacture of a drug product lack the training required to perform their assigned functions.

Registered with FDA for: analysis; label; manufacture; pack; particle size reduction.