Drug factory · FDA FEI 3008768274
Cohance Lifesciences Limited
Plot No. A-19/C, A-23A, & A-23B, Road No. 18, IDA Nacharam, Uppal Mandal, Medchal-Malkajgiri, India
Problems found, fixed voluntarily at FDA's last inspection, Aug 20, 2019.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2013: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 20, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Feb 6, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Jul 12, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 11, 2013 | 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.
Aug 20, 2019 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity. - Approve or reject procedures or specs 21 CFR 211.22(c)
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality and purity of drug products. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
Feb 6, 2018 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. - Written in-process control procedures 21 CFR 211.110(a)
Written procedures are not followed that describe the in-process controls to be conducted on appropriate samples of in-process materials of each batch. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing. - Failure to meet specifications 21 CFR 314.81(b)(1)(ii)
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.
Registered with FDA for: manufacture.