FDA Inspection 983411 — Town and Country Compounding and Consultation Services, LLC
The FDA completed an inspection of Town and Country Compounding and Consultation Services, LLC on August 22, 2016 in Ramsey, NJ. 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 22, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ramsey, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1413 | 21 CFR 211.42(c)(5) | Mfg / Processing Operations Area |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |