FDA Inspection
TopGum Canada LtdTopGum Canada Ltd – FDA Inspection, Apr 1, 2016
Record Details
This FDA Inspection record concerns TopGum Canada Ltd, with an inspection on April 1, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- TopGum Canada Ltd
- Inspection Date
- April 1, 2016
- Product Type
- Drugs
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ID · 699a3977-e5e7-4446-b92c-6fee5c66581c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 967053
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
16- 21 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
- 21 CFR 211.188(b)(10)Records of any sampling performed
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.115(b)Reprocessing/quality control unit
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
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Other FDA inspections of TopGum Canada Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 8, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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