FDA Inspection 729919 — Fareva Richmond, Inc.
The FDA completed an inspection of Fareva Richmond, Inc. on June 21, 2011 in Henrico, VA. 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
- June 21, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Henrico, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |