FDA Inspection 1112488 — LifeHealth Science
The FDA completed an inspection of LifeHealth Science on December 11, 2019 in Twinsburg, OH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 11, 2019
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Twinsburg, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15509 | 21 CFR 111.27(a)(6) | Instruments, controls - accurate, precise, maintained |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 16038 | 21 CFR 111.605(b) | Records - original, true copies |