FDA Inspection 851965 — International Laboratories (Canada) Ltd.
The FDA completed an inspection of International Laboratories (Canada) Ltd. on September 27, 2013 in Calgary. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 27, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Calgary (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |
| 4576 | 21 CFR 211.192 | No written record of investigation |