FDA Inspection 1200642 — Hi-Tech Pharmaceuticals Inc.
The FDA completed an inspection of Hi-Tech Pharmaceuticals Inc. on March 24, 2023 in Norcross, GA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 24, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Norcross, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15625 | 21 CFR 111.180(b)(3) | Documentation - components |
| 15662 | 21 CFR 111.303 | Written procedures - laboratory operations |
| 15665 | 21 CFR 111.303 | Written procedures - tests, examinations; specifications met |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15863 | 21 CFR 111.75(a)(2)(ii)(B) | Component - certificate of analysis |
| 15872 | 21 CFR 111.75(c)(3) | Specifications met identity,purity, strength, comp,; basis |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15931 | 21 CFR 111.105 | Quality control - packaged, labeled |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15985 | 21 CFR 111.123(b)(1) | Quality control - components, identity specifications |
| 15986 | 21 CFR 111.123(b)(2) | Quality control - batch, product specifications |
| 15999 | 21 CFR 111.127(h) | Quality control operations - packaging, labeling; approving, rejecting |