FDA Inspection 727943 — Aurolife Pharma, LLC
The FDA completed an inspection of Aurolife Pharma, LLC on May 25, 2011 in Dayton, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 25, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dayton, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |