Drug factory · FDA FEI 3007574780
Ipca Laboratories Limited
1, Pharma Zone, SEZ, Indore, Pithampur, Dhar, India
Problems found, fixed voluntarily at FDA's last inspection, Jun 23, 2023.
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 2012: 1 with no problems, 2 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Atenolol | Makes it, tests it, packages it and labels it | Ipca Laboratories Limited | 83980-022, 83980-023, 83980-024 |
| Chlorthalidone | Makes it, tests it, packages it and labels it | Ipca Laboratories Limited | 83980-061, 83980-062 |
| Etodolac | Makes it, tests it, packages it and labels it | Ipca Laboratories Limited | 83980-029, 83980-030, 83980-031 +1 |
| Furosemide | Makes it, tests it, packages it and labels it | Ipca Laboratories Limited | 83980-002, 83980-003, 83980-004 |
| Hydroxychloroquine | Makes it, tests it, packages it and labels it | Ipca Laboratories Limited | 83980-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 23, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 17, 2014 | Serious problems, FDA action | Drug Quality Assurance | — |
| Apr 26, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jan 27, 2012 | 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.
Apr 26, 2013 inspection
- Written program not followed 21 CFR 211.166(a)
The written stability testing program is not followed. - Calculations performed are in the records 21 CFR 211.194(a)(5)
Laboratory records do not include a record of all calculations performed in connection with the test. - Second person sign off 21 CFR 211.194(a)(8)
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards.
Registered with FDA for: analysis; label; manufacture; pack.