FDA Inspection 1054191 — Isomers Laboratories Inc.
The FDA completed an inspection of Isomers Laboratories Inc. on May 11, 2018 in North York. 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
- May 11, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- North York (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1918 | 21 CFR 211.166(a)(2) | Stability sample storage conditions described |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4349 | 21 CFR 211.160(b)(2) | In-process samples representative, identified properly |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |