FDA Inspection 1187535 — Regalabs
The FDA completed an inspection of Regalabs on November 4, 2022 in Canton, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 4, 2022
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Canton, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15660 | 21 CFR 111.475(b)(2) | Records - product distribution |
| 15720 | 21 CFR 111.370 | Rejected dietary supplements - identify, hold, control |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15975 | 21 CFR 111.120(e) | Quality control operations - quarantine |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |