FDA Inspection 1280450 — Sparsha Pharma Usa Inc
The FDA completed an inspection of Sparsha Pharma Usa Inc on Sep 4, 2025 in Oceanside, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 4, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Oceanside, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2019 | 21 CFR 211.188(b)(7) | Documentation of Actual Yield and Theoretical Yield |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3607 | 21 CFR 211.160(b)(2) | Acceptance of in-process materials |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |