FDA Inspection 1054722 — Bright Innovation Labs
The FDA completed an inspection of Bright Innovation Labs on June 7, 2018 in Santa Clarita, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 21 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 7, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Santa Clarita, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 16495 | FDCA 601(c) | Insanitary conditions; injurious to health |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 2402 | 21 CFR 211.194(a)(5) | Testing Calculations |
| 2405 | 21 CFR 211.194(a)(7) | Identification of Person Performing the Testing |
| 3553 | 21 CFR 211.48(a) | Plumbing System Defects |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |
| 4309 | 21 CFR 211.84(c)(2) | Containers sampled so as to prevent contamination |
| 4360 | 21 CFR 211.170(b) | Reserve drug product sample quantity - all tests |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |