FDA Inspection 976055 — Private Label Partners, Inc.
The FDA completed an inspection of Private Label Partners, Inc. on Jun 17, 2016 in Santa Ana, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 17, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Santa Ana, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 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 |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2011 | 21 CFR 211.188(a) | Accurate reproduction |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4576 | 21 CFR 211.192 | No written record of investigation |