FDA Inspection 1214910 — Lohxa LLC
The FDA completed an inspection of Lohxa LLC on August 3, 2023 in North Oxford, MA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 3, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- North Oxford, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1927 | 21 CFR 211.166(b) | Accelerated stability studies |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 21295 | 21 CFR 211.110(b) | In-process conformity - examination, sample testing |
| 2620 | 21 CFR 211.198(b)(2) | Complaint Record at Location of Investigation |