FDA Inspection 1222654 — Marudhar Impex
The FDA completed an inspection of Marudhar Impex on November 1, 2023 in Ahmedabad. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 1, 2023
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Ahmedabad (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |