# FDA 483 - Pascal Company Inc - August 21, 2025

Source: https://www.keypedia.com/records/483/pascal-company-inc/c122ac61-cc0a-4cf9-8aec-9accb5ff891b

> FDA 483 for Pascal Company Inc on August 21, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Pascal Company Inc
- Inspection Date: 2025-08-21
- Product Type: drugs
- Office Name: Seattle District Office
- Summary: An FDA inspection of Pascal Company Inc in Bellevue, WA, revealed significant deficiencies in manufacturing controls, laboratory practices, and data integrity. The firm failed to adequately validate manufacturing processes for topical fluoride gels, lacked proper specifications and investigations for out-of-specification results, and exhibited poor controls over computer systems used for testing. These observations indicate a lack of assurance regarding the identity, strength, purity, and quality of their drug products.

## Related Officers

- [Gloria E. Andia](https://www.keypedia.com/people/gloria-e-andia/50f145fd-5e25-4a02-bc59-364bcb02b9c8)
- [Pharmaceutical investigator](https://www.keypedia.com/people/bryan-a-galvez/d1e52abc-5b56-4ffb-af22-90e6733fb73a)

Company: https://www.keypedia.com/companies/pascal-company-inc/29f5062d-72f7-4f12-b38a-a4e3df4e873b

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913