# FDA 483 - Sheffield Pharmaceuticals, LLC - March 15, 2019

Source: https://www.globalkeysolutions.net/records/483/sheffield-pharmaceuticals-llc/7142db62-5e29-4696-b632-39acc3175dcf

> FDA 483 for Sheffield Pharmaceuticals, LLC on March 15, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sheffield Pharmaceuticals, LLC
- Inspection Date: 2019-03-15
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Sheffield Pharmaceuticals, LLC in New London, CT, revealed multiple significant deficiencies across various quality system procedures. The firm was cited for inadequate procedures related to design change, corrective and preventive actions, nonconforming product disposition, equipment calibration and maintenance, complaint handling, and document control. These observations indicate a systemic lack of robust quality management practices.

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- [483 - 2025-06-18](https://www.globalkeysolutions.net/records/483/sheffield-pharmaceuticals-llc/7cd01947-9bfa-44de-b786-afdb286b6669)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)

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

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7