Drug factory · FDA FEI 1510690

West-Ward Columbus 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.