FDA Inspection 1084590 — Precious Cosmetics Packaging and Consulting Corp.
The FDA completed an inspection of Precious Cosmetics Packaging and Consulting Corp. on April 1, 2019 in Lodi, NJ. 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
- April 1, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lodi, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2011 | 21 CFR 211.188(a) | Accurate reproduction |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |