FDA Inspection 1237109 — BodyBio Inc.
The FDA completed an inspection of BodyBio Inc. on April 26, 2024 in Millville, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 26, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Millville, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15779 | 21 CFR 111.415(a) | Clean, sanitize - filling, packaging equipment |
| 15783 | 21 CFR 111.410(d) | Manufacturing history |
| 15800 | 21 CFR 111.560(a)(2) | Product complaint - quality control investigate |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15864 | 21 CFR 111.75(a)(2)(ii)(C) | Documentation - qualify supplier |
| 15865 | 21 CFR 111.75(a)(2)(ii)(D) | Re-confirm certificate of analysis |
| 15968 | 21 CFR 111.117(c) | Quality control operations - equipment records |