# FDA 483 - Sparsha Pharma Usa Inc - September 04, 2025

Source: https://www.keypedia.com/records/483/sparsha-pharma-usa-inc/5d8ea022-2008-4bfa-a77d-7cb8d4985241

> FDA 483 for Sparsha Pharma Usa Inc on September 04, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sparsha Pharma Usa Inc
- Inspection Date: 2025-09-04
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: Sparsha Pharma Usa Inc. in Oceanside, CA, received a Form FDA 483 with 10 observations during an inspection from August 25 to September 4, 2025, for its OTC drug and medical device manufacturing operations. The observations highlight significant deficiencies across laboratory controls, data integrity, quality systems, production records, and material warehousing, including repeat observations related to unverified spreadsheets and CAPA documentation. These issues indicate a systemic lack of adherence to cGMP and medical device quality system regulations, potentially compromising product quality and reliability.

## Related Officers

- [Navneet Kaur](https://www.keypedia.com/people/navneet-kaur/23db67cc-7589-46f9-bbb9-930c0460500f)
- [Cecilia H. Kieu](https://www.keypedia.com/people/cecilia-h-kieu/3ba5feb0-d49e-4301-ae5c-b84bd604a159)
- [Director of Investigations Branch](https://www.keypedia.com/people/katherine-e-jacobitz/9a713b44-95c4-43a2-83bb-8d30062d8345)
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- [Public Affairs Specialist](https://www.keypedia.com/people/joey-v-quitania/faae874f-94ea-4b63-89d1-649e60726f6f)

Company: https://www.keypedia.com/companies/sparsha-pharma-usa-inc/77df80d8-0675-408b-9920-0b7da0360374

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b