# FDA 483 - SV Labs Prescott Corporation - June 13, 2025

Source: https://www.keypedia.com/records/483/sv-labs-prescott-corporation/befe73ce-cc63-4bdd-9c82-6214b5120767

> FDA 483 for SV Labs Prescott Corporation on June 13, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SV Labs Prescott Corporation
- Inspection Date: 2025-06-13
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: SV Labs Prescott Corporation received a Form 483 with 14 observations, primarily citing significant deficiencies in their manufacturing and quality control operations for OTC finished drug products. Key issues include a complete lack of process validation, the release of out-of-specification products, and inadequate laboratory controls for microbial testing and investigations. The firm also demonstrated poor record-keeping, insufficient equipment qualification, and a lack of proper personnel training, with some issues being repeat observations.

## Related Documents

- [483 - 2018-09-28](https://www.keypedia.com/records/483/sv-labs-prescott-corporation/0bea7edd-a20f-49e1-8ff7-736bc60e6c9b)
- [WARNING_LETTER - 2025-06-13](https://www.keypedia.com/records/warning_letter/sv-labs-prescott-corporation/dd878dd8-b4c8-4144-8624-22a327d773d3)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/michael-o-idowu/795647ab-8f6b-47cc-ae88-3b2c61192861)
- [Olumide A. Akinyemi](https://www.keypedia.com/people/olumide-a-akinyemi/a520acd2-450c-4624-a7af-b871e4fad9c7)
- [Investigator](https://www.keypedia.com/people/pushpa-s-jayasekara/cfd7d22f-b4c2-4002-ae18-b5435815d27d)

Company: https://www.keypedia.com/companies/sv-labs-prescott-corporation/3fa073ed-17f3-40c6-930b-6f5b2905ee5d

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d