FDA Inspection 1267971 — Innocore Sales & Marketing Inc.
The FDA completed an inspection of Innocore Sales & Marketing Inc. on April 25, 2025 in Woodstock. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 25, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Woodstock (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1388 | 21 CFR 211.101(d) | Component addition checked by 2nd person |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |