Drug factory · FDA FEI 3004097901
Granules India Limited
Sy.No. 160/A, 161/E, 162, 174/A, Gagillapur Village, Dundigal-Gandimaisamma Mandal, Medchal-Malkajgiri District, India
Problems found, fixed voluntarily at FDA's last inspection, Feb 14, 2020.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2009: 4 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 14, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Mar 23, 2018 | No problems found | Drug Quality Assurance | — |
| Oct 14, 2016 | No problems found | Drug Quality Assurance | — |
| Mar 13, 2015 | No problems found | Drug Quality Assurance | — |
| Sep 13, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 12, 2009 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Feb 14, 2020 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration and inspection of electronic equipment is not performed according to a written program designed to assure proper performance.
Registered with FDA for: analysis; label; manufacture; pack.