FDA Inspection 1013046 — VitaCare Pharma, LLC
The FDA completed an inspection of VitaCare Pharma, LLC on May 22, 2017 in South Plainfield, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 22, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- South Plainfield, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15545 | 21 CFR 111.260(e) | Batch record - component; identity, weight |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15872 | 21 CFR 111.75(c)(3) | Specifications met identity,purity, strength, comp,; basis |
| 15973 | 21 CFR 111.120(c) | Quality control operations - material review, disposition decision |