FDA Inspection 1152351 — Logix Biosciences Inc.
The FDA completed an inspection of Logix Biosciences Inc. on September 20, 2021 in Monterey, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 20, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Monterey, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |
| 4576 | 21 CFR 211.192 | No written record of investigation |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |