FDA Inspection 938641 — Shine & Pretty (USA), Corp.
The FDA completed an inspection of Shine & Pretty (USA), Corp. on August 12, 2015 in Camarillo, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 12, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Camarillo, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |