FDA Inspection
Contract Pharmaceuticals Limited CanadaContract Pharmaceuticals Limited Canada – FDA Inspection, Mar 29, 2018
Record Details
This FDA Inspection record concerns Contract Pharmaceuticals Limited Canada, with an inspection on March 29, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 77085557-cd1e-40c3-8b16-d533de67fc25
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1047010
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.82(a)Examination on receipt, before acceptance
- 21 CFR 211.84(d)(2)Establish reliability of supplier's C of A
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Other FDA inspections of Contract Pharmaceuticals Limited Canada
6| Date | Classification | Office | Project area |
|---|---|---|---|
| November 3, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 17, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 31, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 11, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 24, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Contract Pharmaceuticals Limited Canada
- FDA Inspection 1221751 - 2023-11-03
- FDA Inspection 1092575 - 2019-05-17
- FDA Inspection 1012913 - 2017-03-31
- FDA Inspection 880142 - 2014-04-11
- FDA Inspection 770648 - 2012-02-24
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