Drug factory · FDA FEI 3005124189
Indoco Remedies Limited
Goa Plant-II & III, L-32, 33, 34, Verna Industrial Area, Verna, Goa, India
Serious problems, FDA action at FDA's last inspection, Feb 28, 2023.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
6 drug inspections on record since 2011: 0 with no problems, 3 with problems fixed voluntarily, 3 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 28, 2023 | Serious problems, FDA action | Drug Quality Assurance | 4 |
| Nov 21, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Sep 4, 2016 | Serious problems, FDA action | Drug Quality Assurance | — |
| Jul 10, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 30, 2013 | Serious problems, FDA action | Drug Quality Assurance | — |
| Feb 23, 2011 | 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.
Feb 28, 2023 inspection
- Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components conform to appropriate standards of identity, strength, quality and purity. - Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. - Equipment to control conditions 21 CFR 211.42(c)(10)(vi)
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
Nov 21, 2018 inspection
- Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are deficiently 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 in writing and fully followed.
Registered with FDA for: analysis; label; manufacture; pack.