FDA Inspection 1102451 — Private Label Partners, Inc.
The FDA completed an inspection of Private Label Partners, Inc. on September 13, 2019 in Santa Ana, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 13, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Santa Ana, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |
| 4576 | 21 CFR 211.192 | No written record of investigation |