Drug factory · FDA FEI 3006230648
Marksans Pharma Limited
Plot No L-82 & L-83, Verna Industrial Estate, , Verna, India
Problems found, fixed voluntarily at FDA's last inspection, Apr 17, 2024.
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: 2 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 |
|---|---|---|---|
| Apr 17, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 4, 2023 | Problems found, fixed voluntarily | Bioresearch Monitoring | 2 |
| Apr 7, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 3, 2015 | No problems found | Drug Quality Assurance | — |
| Aug 3, 2012 | No problems found | Drug Quality Assurance | — |
| Nov 13, 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.
Aug 4, 2023 inspection
- Failure to submit ADE report 21 CFR 310.305(c)
Adverse drug experience information has not been reported to FDA. - Failure to develop written procedures 21 CFR 314.80(b)
Written procedures have not been developed for the surveillance, receipt, evaluation and reporting to FDA of post marketing adverse drug experiences.
Registered with FDA for: manufacture.