FDA Inspection 1045211 — Coastal Contract Packaging, Inc
The FDA completed an inspection of Coastal Contract Packaging, Inc on March 22, 2018 in Ventura, CA. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 22, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ventura, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1413 | 21 CFR 211.42(c)(5) | Mfg / Processing Operations Area |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |