FDA Inspection 1054836 — TopGum Canada Ltd
The FDA completed an inspection of TopGum Canada Ltd on Jun 8, 2018 in Charlottetown. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 8, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Charlottetown (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |