Drug factory · FDA FEI 3012448465
Strides Pharma Science Limited
R. S. No. 31, 32 and 33 PIMS Road, Periyakalapet, Puducherry, India
Problems found, fixed voluntarily at FDA's last inspection, Feb 24, 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 2019: 0 with no problems, 1 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amantadine | Makes it, tests it and packages it | Vensun Pharmaceuticals, Inc. | 42543-493, 42543-497 |
| Anhydrous Citric Acid | Makes it, tests it and packages it | Vensun Pharmaceuticals, Inc. | 42543-406, 42543-407, 42543-408 |
| Cinacalcet | Makes it, tests it and packages it | Strides Pharma Science Limited | 64380-883, 64380-884, 64380-885 |
| Fluoxetine | Makes it, tests it and packages it | Strides Pharma Science Limited | 64380-900, 64380-902, 64380-903 |
| Gabapentin | Makes it, tests it and packages it | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., Medsource Pharmaceuticals, Strides Pharma Science Limited | 23155-866, 23155-867, 23155-868 +6 |
| Ibuprofen | Makes it, tests it and packages it | Strides Pharma Science Limited | 64380-807, 64380-808, 64380-809 |
| Nystatin | Makes it, tests it and packages it | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-051 |
| Sevelamer | Makes it, tests it and packages it | Strides Pharma Science Limited | 64380-872 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 24, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Feb 5, 2019 | Serious problems, FDA action | 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 24, 2023 inspection
- Complete instructions, procedures, specifications et. al. 21 CFR 211.186(b)(9)
Master production and control records lack complete manufacturing and control instructions, special notations and precautions to be followed. - 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 in writing and fully followed. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product. - 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; manufacture; pack.