FDA Inspection 1062404 — LGM Pharma Solutions, LLC
The FDA completed an inspection of LGM Pharma Solutions, LLC on Aug 17, 2018 in Irvine, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 17, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Irvine, CA (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 18033 | 21 CFR 314.80(g)(1) | Failure to submit electronic format safety report |
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6833 | 21 CFR 314.80(c)(2)(ii)(A) | Incomplete periodic safety report |
| 8912 | 21 CFR 314.81(b)(2) | Timely submission |