FDA Inspection 1061500 — Fill It Pack It Inc
The FDA completed an inspection of Fill It Pack It Inc on August 8, 2018 in Compton, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 8, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Compton, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1421 | 21 CFR 211.42(c)(10) | Aseptic Processing Area |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 2011 | 21 CFR 211.188(a) | Accurate reproduction |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |