Sparsha Pharma Usa Inc
Form 483 issued September 4, 2025 · Oceanside, California
- Inspection
- Aug 25 – Sep 4, 2025
- Investigators
- Cecilia H. Kieu· Crystal Monroy· Joey V. Quitania
- Observations
- 10
- Pages
- 13
- FEI number
- 3010888655
In short: On September 4, 2025, FDA issued a Form 483 with 10 observations to Sparsha Pharma Usa Inc in Oceanside, California (FEI 3010888655) after an inspection that ran Aug 25 – Sep 4, 2025. The investigators were Cecilia H. Kieu, Crystal Monroy, Joey V. Quitania, Katherine E. Jacobitz and Navneet Kaur. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 03
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
- 04
The establishment of laboratory control mechanisms including any changes thereto, are not reviewed and approved by…
This inspection in context
Cecilia H. Kieu
13 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmSparsha Pharma Usa Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sparsha Pharma Usa Inc?
FDA listed 10 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Sparsha Pharma Usa Inc?
Cecilia H. Kieu, Crystal Monroy, Joey V. Quitania, Katherine E. Jacobitz and Navneet Kaur are named on this Form 483, for the inspection of Aug 25 – Sep 4, 2025. Each investigator has a profile showing what they cite most.
When was Sparsha Pharma Usa Inc inspected by FDA?
The inspection ran Aug 25 – Sep 4, 2025, and the Form 483 is dated September 4, 2025.
How do I get the full Form 483 for Sparsha Pharma Usa Inc?
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