FDA Inspection 1093310 — Novocol Pharmaceutical of Canada, Inc.

Novocol Pharmaceutical of Canada, Inc. — FEI 3002807757

The FDA completed an inspection of Novocol Pharmaceutical of Canada, Inc. on June 18, 2019 in Cambridge. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 18, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Cambridge (Canada)

Citations

IDCFRDescription
145121 CFR 211.113(b)Procedures for sterile drug products