FDA Inspection
TopGum Canada LtdTopGum Canada Ltd – FDA Inspection, Jun 8, 2018
Record Details
This FDA Inspection record concerns TopGum Canada Ltd, with an inspection on June 8, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · cbbd6b0e-4239-4f58-9121-aa7975e8fa5f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1054836
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.182Specific information required in individual logs
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of TopGum Canada Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 1, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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