FDA Inspection 662789 — LPNA Group Inc.
The FDA completed an inspection of LPNA Group Inc. on May 7, 2010 in Tonawanda, NY. 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 7, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tonawanda, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |