Drug factory · FDA FEI 3019037664
Cohance Lifesciences Limited
Survey No. 99/1, Plot No-9A(1), Mamidipally Village, Balapur Mandal, Samshabad, Rangareddy, India
Problems found, fixed voluntarily at FDA's last inspection, Jul 12, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2024: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Allopurinol | Makes it, tests it, packages it and labels it | Rising Pharma Holdings, Inc. | 16571-883, 16571-884, 16571-885 |
| Anhydrous Citric Acid | Makes it, tests it, packages it and labels it | Rising Pharma Holdings, Inc. | 16571-864, 16571-865 |
| Colchicine and Probenecid | Makes it, tests it, packages it and labels it | Rising Pharma Holdings, Inc. | 16571-832 |
| Dapsone | Makes it, tests it, packages it and labels it | Rising Pharma Holdings, Inc. | 64980-566, 64980-567 |
| Dicyclomine | Makes it, tests it, packages it and labels it | Rising Pharma Holdings, Inc. | 16571-259, 16571-260 |
| Fenoprofen | Makes it, tests it, packages it and labels it | Galt Pharmaceuticals, LLC | 61825-311 |
| Phenoxybenzamine | Makes it, tests it, packages it and labels it | Rising Pharma Holdings, Inc. | 16571-874 |
| Potassium Cation | Makes it, tests it, packages it and labels it | Rising Pharma Holdings, Inc. | 16571-842, 16571-843 |
| Probenecid | Makes it, tests it, packages it and labels it | Rising Pharma Holdings, Inc. | 16571-831 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 12, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jul 12, 2024 inspection
- Records not made readily available to FDA 21 CFR 211.180(c)
Records associated with drug product components, production and control and within the retention period for such records, were not made readily available for authorized inspection. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Registered with FDA for: analysis; label; manufacture; pack; relabel; repack.