FDA Inspection 967053 — TopGum Canada Ltd
The FDA completed an inspection of TopGum Canada Ltd on Apr 1, 2016 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). 16 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 1, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Charlottetown (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1456 | 21 CFR 211.115(b) | Reprocessing/quality control unit |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1876 | 21 CFR 211.180(b) | Record maintenance 1 year (except exempt OTC) |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3588 | 21 CFR 211.110(a)(3) | Mixing adequacy |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |
| 4370 | 21 CFR 211.188(b)(10) | Records of any sampling performed |
| 4373 | 21 CFR 211.188(b)(7) | Actual yield, % of theoretical yield |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |