Drug factory · FDA FEI 3025926685
Ritsa Pharma Private Limited
Neovantage Park, Building-1800, 3600 (Chemical Store) Genome Valley, SY No. 101, 101/2, 340, Lalgadi Malakpet, Shamirpet, Medchal Malkajgiri, Hyderabad, India
Problems found, fixed voluntarily at FDA's last inspection, Sep 5, 2025.
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 2025: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Cabergoline | Makes it | SKG Pharma Inc. | 83085-003 |
| Nicardipine | Makes it | SKG Pharma Inc. | 83085-001, 83085-002 |
| Prucalopride | Makes it | Amneal Pharmaceuticals, SKG Pharma Inc. | 69238-2698, 69238-2699, 83085-005 +1 |
| Rasagiline | Makes it | Rising Pharma Holdings, Inc., SKG Pharma Inc. | 64980-711, 64980-712, 83085-007 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 5, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Sep 5, 2025 inspection
- Establish reliability of supplier's C of A 21 CFR 211.84(d)(2)
Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
Registered with FDA for: manufacture.