# FDA 483 - Pharmasol Corporation - February 10, 2022

Source: https://www.globalkeysolutions.net/records/483/pharmasol-corporation/6f83e99a-c5ff-4088-bf2b-f75f2264696f

> FDA 483 for Pharmasol Corporation on February 10, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmasol Corporation
- Inspection Date: 2022-02-10
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Pharmasol Corporation, a human and animal drug contract manufacturer in South Easton, MA, was cited for numerous significant deficiencies during an FDA inspection. The observations highlight systemic failures in quality control, including inadequate investigations into complaints and cleaning failures, lack of proper equipment maintenance, and insufficient employee training. These issues indicate a broad lack of adherence to cGMP regulations, posing potential risks to drug product quality and patient safety.

## Related Documents

- [483 - 2015-07-16](https://www.globalkeysolutions.net/records/483/pharmasol-corporation/725a8105-8f2d-4c7d-8d5a-ed9977439ab3)
- [483 - 2018-08-20](https://www.globalkeysolutions.net/records/483/pharmasol-corporation/75e0111a-28f1-4400-82b4-86234cea0565)
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- [483 - 2021-06-14](https://www.globalkeysolutions.net/records/483/pharmasol-corporation/a649cc8f-e374-4cf5-bfb5-c02239cf6f28)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/leanna-m-slarsky/9b79fd53-ec91-42bf-aba4-ab106fee9cbc)
- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.globalkeysolutions.net/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)

Company: https://www.globalkeysolutions.net/companies/pharmasol-corporation/7961d42d-8409-45eb-8448-c0f2729ef17c

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