FDA Inspection 1101454 — Forma Life Sciences, Inc
The FDA completed an inspection of Forma Life Sciences, Inc on September 6, 2019 in Irvine, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 6, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2402 | 21 CFR 211.194(a)(5) | Testing Calculations |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |