FDA Inspection 872676 — Pharmakon Pharmaceuticals, Inc.
The FDA completed an inspection of Pharmakon Pharmaceuticals, Inc. on April 8, 2014 in Noblesville, IN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 8, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Noblesville, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1633 | 21 CFR 211.130(d) | Examination of packaging and labeling |
| 1725 | 21 CFR 211.134(c) | Examinations documented |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |