FDA Inspection 1155013 — NatureLab Corp.
The FDA completed an inspection of NatureLab Corp. on October 22, 2021 in Carrollton, TX. 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: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 22, 2021
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Carrollton, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15542 | 21 CFR 111.260(b) | Batch record - date, time; maintenance |
| 15544 | 21 CFR 111.260(d) | Batch record - component; unique identifier |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15810 | 21 CFR 111.570(b)(2) | Record - product complaint; good manufacturing practice |
| 15826 | 21 CFR 111.65 | Quality control - packaged, labeled |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15933 | 21 CFR 111.105(b) | Quality control - supplier qualification |
| 15938 | 21 CFR 111.105(f) | Quality control - representative samples |