Drug factory · FDA FEI 3002806710
Cipla Limited
Plot No. A-2, A-33, A-42 and A-37/2/2, Patalganga Industrial Area, Raigad, India
Problems found, fixed voluntarily at FDA's last inspection, Apr 4, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2009: 2 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 4, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 13, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 6, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 9 |
| Oct 16, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 27, 2015 | No problems found | Drug Quality Assurance | — |
| Jun 6, 2012 | No problems found | Drug Quality Assurance | — |
| Feb 6, 2009 | Problems found, fixed voluntarily | 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.
Dec 6, 2017 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions. - Following/documenting laboratory controls 21 CFR 211.160(a)
Established test procedures and laboratory control mechanisms are not followed. - Written program not followed 21 CFR 211.166(a)
The written stability testing program is not followed. - Results of drug product inspections and examinations 21 CFR 211.188(b)(13)
The batch production and control records are deficient in that they do not include results of drug product inspections. - Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and 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. - Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are not written or followed. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture and processing of a drug product lack the training and experience required to perform their assigned functions.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.