FDA Inspection 901353 — Patanjali Ayurved Limited
The FDA completed an inspection of Patanjali Ayurved Limited on September 3, 2014 in Haridwar. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 3, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Haridwar (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15733 | 21 CFR 111.365 | Manufacturing operations - prevent contamination |
| 15737 | 21 CFR 111.210(h)(5) | Corrective action plans |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15899 | 21 CFR 111.83(b)(1) | Reserve sample container-closure contamination,deterioration |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15935 | 21 CFR 111.105(d) | Quality control - basis; tests, examinations |
| 15949 | 21 CFR 111.110(a) | QC-Laboratory control processes; production, process control |