FDA Inspection 942763 — RXQ Compounding LLC
The FDA completed an inspection of RXQ Compounding LLC on September 21, 2015 in Albany, OH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 21, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Albany, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 1933 | 21 CFR 211.167(a) | Sterility/pyrogens - test methods written, followed |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4371 | 21 CFR 211.188(b)(9) | Description of containers and closures |