# FDA 483 - Sheffield Pharmaceuticals, LLC - June 18, 2025

Source: https://www.globalkeysolutions.net/records/483/sheffield-pharmaceuticals-llc/7cd01947-9bfa-44de-b786-afdb286b6669

> FDA 483 for Sheffield Pharmaceuticals, LLC on June 18, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sheffield Pharmaceuticals, LLC
- Inspection Date: 2025-06-18
- Product Type: device
- Office Name: New England District Office
- Summary: Sheffield Pharmaceuticals, LLC, a drug and medical device manufacturer in New London, CT, received a Form FDA 483 citing significant quality system deficiencies. Observations included failures to thoroughly investigate deviations for finished drug products, inadequate facility maintenance with active roof leaks, and overdue annual product reviews. Additionally, the firm was cited for issues with medical device design controls and incomplete device history records regarding Unique Device Identification.

## Related Documents

- [483 - 2019-03-15](https://www.globalkeysolutions.net/records/483/sheffield-pharmaceuticals-llc/7142db62-5e29-4696-b632-39acc3175dcf)

## Related Officers

- [Ogechi C. Nna](https://www.globalkeysolutions.net/people/ogechi-c-nna/59452184-8197-4ba6-bf1d-78a7e003ef2c)
- [Power Trader/Data Scientist](https://www.globalkeysolutions.net/people/jeffrey-j-thibodeau/62b74030-4aef-400b-8ae2-8bf84712d813)

Company: https://www.globalkeysolutions.net/companies/sheffield-pharmaceuticals-llc/76465435-d9b6-49f9-a5fd-86ab54bc266d

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144