FDA Inspection
Sparsha Pharma Usa IncSparsha Pharma Usa Inc – FDA Inspection, Sep 3, 2026
Record Details
This FDA Inspection record concerns Sparsha Pharma Usa Inc, with an inspection on September 3, 2026, issued by the Los Angeles District Office, covering human drugs.
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ID · 77456d6f-4abf-49cb-acba-e5b0c40edb2f
Inspection Facts
- Inspection number
- 1334198
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.130(e)Packaging line inspection after use
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.186(b)(7)Theoretical Yield and Percentages
- 21 CFR 211.84(c)(4)Top/Middle/Bottom container sampling
- 21 CFR 211.84(d)(2)Establish reliability of supplier's C of A
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Other FDA inspections of Sparsha Pharma Usa Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 4, 2025 | VAI | Los Angeles District Office | Drug Quality Assurance |
| April 28, 2017 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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