FDA Inspection 774391 — Private Label Partners, Inc.
The FDA completed an inspection of Private Label Partners, Inc. on Mar 14, 2012 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 14, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Santa Ana, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4325 | 21 CFR 211.110(a) | Control procedures fail to include the following |
| 4370 | 21 CFR 211.188(b)(10) | Records of any sampling performed |