Drug factory · FDA FEI 3009150119
Recipharm Pharmaservices Private Limited
Khata No. 845/713 and 1108/970/1, 34th KM, Tumkur Road, (NH 4) Teppada Begur, Nelamangala Taluk, Bengaluru, India
No problems found at FDA's last inspection, Mar 22, 2024.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2012: 3 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Atorvastatin | Makes it | Biocon Pharma Inc. | 70377-077, 70377-078, 70377-079 +1 |
| Bedaquiline | Makes it and tests it | Janssen Products LP | 59676-701, 59676-702 |
| Doxylamine and Pyridoxine | Makes it | Bionpharma Inc. | 69452-206 |
| Etravirine | Makes it | Bionpharma Inc. | 69452-254, 69452-255 |
| Loperamide | Makes it | Bionpharma Inc. | 69452-271 |
| Rosuvastatin | Makes it | Biocon Pharma Inc. | 70377-006, 70377-007, 70377-008 +1 |
| Theophylline | Makes it | Bionpharma Inc. | 69452-267 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 22, 2024 | No problems found | Drug Quality Assurance | — |
| Feb 13, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Feb 1, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 11, 2018 | No problems found | Drug Quality Assurance | — |
| Mar 19, 2015 | No problems found | Drug Quality Assurance | — |
| Nov 1, 2012 | Problems found, fixed voluntarily | 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 13, 2020 inspection
- Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine inspection and checking of automatic, mechanical and electronic equipment is not performed according to a written program designed to assure proper performance. Electronic records are used, but they do not meet retention, system access limitation and audit trail requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.
Registered with FDA for: analysis; label; manufacture; pack.