FDA Inspection 928801 — Compounding Pharmacy of America
The FDA completed an inspection of Compounding Pharmacy of America on May 21, 2015 in Knoxville, TN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 16 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 21, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Knoxville, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1431 | 21 CFR 211.42(c)(10)(ii) | Temperature / Humidity Controls |
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1869 | 21 CFR 211.94(c) | Containers & Closures Clean, Sterilized, Pyrogen-free |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |