FDA Inspection 1156890 — Colorful Products Corporation
The FDA completed an inspection of Colorful Products Corporation on November 17, 2021 in Newbury Park, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 17, 2021
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Newbury Park, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1927 | 21 CFR 211.166(b) | Accelerated stability studies |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4576 | 21 CFR 211.192 | No written record of investigation |