Drug factory · FDA FEI 3008581988
Cipla Limited
Plot No. 9 &10 Indore Special Economic Zone, Phase II - Pithampur, District Dhar, Indore, India
Serious problems, FDA action at FDA's last inspection, Feb 17, 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 2012: 2 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|
| Albuterol | Makes it, tests it, packages it and labels it |
Cipla USA., Inc. |
69097-142 |
| Albuterol and Ipratropium | Makes it, tests it, packages it and labels it |
Cipla USA., Inc. |
69097-173 |
| Amlodipine | Makes it, tests it, packages it and labels it |
Cipla USA., Inc. |
69097-126, 69097-127, 69097-128 |
| Arformoterol | Makes it, tests it, packages it and labels it |
Cipla USA., Inc. |
69097-168 |
| Budesonide | Makes it |
Cipla USA., Inc., Exelan Pharmaceuticals, Inc. |
69097-318, 69097-319, 69097-321 +3 |
| Celecoxib | Makes it, tests it, packages it and labels it |
Cipla USA., Inc., Northstar Rx LLC., Quallent Pharmaceuticals Health LLC |
69097-421, 69097-422, 16714-731 +5 |
| Entecavir | Makes it, tests it, packages it and labels it |
Cipla USA., Inc., Northstar Rx LLC. |
69097-425, 69097-426, 16714-717 +1 |
| Fenofibric Acid | Makes it, tests it, packages it and labels it |
Cipla USA., Inc. |
69097-458, 69097-459 |
| Griseofulvin | Makes it, tests it, packages it and labels it |
Cipla USA., Inc. |
69097-361 |
| Metoprolol | Makes it, tests it, packages it and labels it |
BluePoint Laboratories., Cipla USA., Inc. |
68001-469, 68001-470, 68001-471 +3 |
| Sumatriptan | Makes it, tests it, packages it and labels it |
Cipla USA., Inc. |
69097-644 |
| Zidovudine | Makes it, tests it, packages it and labels it |
Cipla Ltd. |
53104-0105 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|
| Feb 17, 2023 | Serious problems, FDA action | Drug Quality Assurance | — |
| May 17, 2019 | No problems found | Drug Quality Assurance | — |
| Apr 13, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 7, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 1, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 2, 2012 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.