FDA Inspection 971560 — Pharmakon Compounding Pharmacy, Inc.
The FDA completed an inspection of Pharmakon Compounding Pharmacy, Inc. on May 6, 2016 in Noblesville, IN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 6, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Noblesville, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1266 | 21 CFR 211.42(d) | Penicillin processing area not kept separate |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1436 | 21 CFR 211.42(c)(10)(vi) | Equipment to control conditions |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |