FDA Inspection 887244 — LGM Pharma Solutions, LLC
The FDA completed an inspection of LGM Pharma Solutions, LLC on July 11, 2014 in Irvine, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 11, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 110 | 21 CFR 606.120(b)(2) | Destruction of obsolete labels |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3569 | 21 CFR 211.89 | Quarantine of Rejected Components et. al. |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 4356 | 21 CFR 211.166(b) | Tentative expiration date |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 4576 | 21 CFR 211.192 | No written record of investigation |