Drug factory · FDA FEI 3012520698
Concord Biotech Limited
Unit - II, 297-298 / 2P At Valthera Ta. Dholka, Ahmedabad, India
Problems found, fixed voluntarily at FDA's last inspection, Mar 17, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2018: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Mycophenolic Acid | Makes it, tests it, packages it and labels it | Advagen Pharma Ltd., Concord Biotech Limited, Stellon Biotech Inc. | 72888-199, 72888-200, 68254-5000 +5 |
| Tacrolimus | Makes it, tests it, packages it and labels it | Concord Biotech Limited, Stellon Biotech Inc. | 68254-5004, 68254-5005, 68254-5006 +3 |
| Teriflunomide | Makes it, tests it, packages it and labels it | Concord Biotech Limited | 68254-5010, 68254-5013 |
| Tofacitinib | Makes it, tests it, packages it and labels it | Concord Biotech Limited, Stellon Biotech Inc. | 68254-5011, 68254-5012, 85972-121 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 17, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Feb 16, 2018 | 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.
Mar 17, 2023 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. - 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.
Registered with FDA for: analysis; label; manufacture; pack.