FDA Inspection 1153356 — Patanjali Ayurved Limited
The FDA completed an inspection of Patanjali Ayurved Limited on September 30, 2021 in Haridwar. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 30, 2021
- Fiscal Year
- 2021
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Haridwar (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 15671 | 21 CFR 111.315 | Laboratory control processes - requirements |
| 15712 | 21 CFR 111.325(b)(2)(ii) | Records - document; results |
| 15723 | 21 CFR 111.365(i) | Metal, foreign material |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15953 | 21 CFR 111.113(a)(1) | Quality control production, process control; material review, disposition |