# FDA 483 - Digestive Care Inc - June 27, 2023

Source: https://www.globalkeysolutions.net/records/483/digestive-care-inc/bb0cbe84-c9cf-4c89-87f1-02e993b43095

> FDA 483 for Digestive Care Inc on June 27, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Digestive Care Inc
- Inspection Date: 2023-06-27
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Digestive Care Inc. in Bethlehem, PA, a human drug manufacturer, was cited for failing to store drug products under appropriate temperature and humidity conditions. The inspection revealed that several storage areas, including those for active pharmaceutical ingredients, capsules, and finished products, lacked scientific-driven temperature mapping studies and rationale for data logger placement. Additionally, the controlled temperature warehouse had not undergone seasonal temperature mapping.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/karen-a-briggs/3e77d364-25ea-48c7-87f4-36f3e170bfb5)

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

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8