FDA Inspection
Novocol Pharmaceutical of Canada, Inc.Novocol Pharmaceutical of Canada, Inc. – FDA Inspection, Jul 26, 2017
Record Details
This FDA Inspection record concerns Novocol Pharmaceutical of Canada, Inc., with an inspection on July 26, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · da862aae-318c-4735-bb6c-6b113e69b6ce
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1019963
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 314.80(b)Failure to develop written procedures
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Other FDA inspections of Novocol Pharmaceutical of Canada, Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| May 3, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 30, 2020 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 21, 2019 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 18, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 2, 2018 | Not classified | Office of Inspections and Investigations |
Other documents for Novocol Pharmaceutical of Canada, Inc.
- FDA Inspection 1243223 - 2024-05-03
- FDA Inspection 1117454 - 2020-01-30
- FDA Inspection 1098218 - 2019-06-21
- FDA Inspection 1093310 - 2019-06-18
- FDA Inspection 1072908 - 2018-11-02
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