FDA Inspection 988007 — Maneesh Pharmaceuticals Limited
The FDA completed an inspection of Maneesh Pharmaceuticals Limited on Jul 13, 2016 in Mumbai. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 13, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Mumbai (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15551 | 21 CFR 111.260(j)(1) | Batch record - date, each step |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15737 | 21 CFR 111.210(h)(5) | Corrective action plans |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |