# FDA 483 - Digestive Care Inc - May 05, 2026

Source: https://www.keypedia.com/records/483/digestive-care-inc/7b6d47af-6b6a-4a70-a845-064770468a92

> FDA 483 for Digestive Care Inc on May 05, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Digestive Care Inc
- Inspection Date: 2026-05-05
- Product Type: drugs
- Office Name: FDA District Office — Philadelphia, Pennsylvania
- Summary: An FDA inspection of Digestive Care Inc. in Bethlehem, PA, revealed significant deficiencies in equipment cleaning and validation practices. The firm failed to demonstrate that manufacturing equipment was free of residual agents and lacked proper cleaning verification or validation studies. This raises concerns about potential contamination and the safety, identity, strength, quality, or purity of their drug products.

## Related Documents

- [483 - 2023-06-27](https://www.keypedia.com/records/483/digestive-care-inc/bb0cbe84-c9cf-4c89-87f1-02e993b43095)

## Related Officers

- [Ruben C. Quintana](https://www.keypedia.com/people/ruben-c-quintana/fbf0f0ef-eb51-4a06-a4b9-f7856fa06c58)

Company: https://www.keypedia.com/companies/digestive-care-inc/c4de8703-81c2-4afc-9e51-392b626b8e63

Office: https://www.keypedia.com/offices/fda-district-office-philadelphia-pennsylvania/e70a6e70-40b2-49e4-8360-c3db36c4d2a0