FDA Inspection 896153 — Mihalko Medical, LLC
The FDA completed an inspection of Mihalko Medical, LLC on September 18, 2014 in Pittsburgh, PA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 18, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pittsburgh, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 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 |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |