# FDA 483 - Pharmasol Corporation - June 14, 2021

Source: https://www.globalkeysolutions.net/records/483/pharmasol-corporation/a649cc8f-e374-4cf5-bfb5-c02239cf6f28

> FDA 483 for Pharmasol Corporation on June 14, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmasol Corporation
- Inspection Date: 2021-06-14
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Pharmasol Corporation, a human drug contract manufacturer in South Easton, MA, revealed significant and repeat deficiencies across multiple areas of its operations. The firm failed to thoroughly investigate numerous discrepancies impacting distributed drug products, including illegible expiration dates, broken actuators, and stability failures. Additionally, the inspection found inadequate quality control unit procedures, insufficient equipment qualification, failures to follow production controls, dirty manufacturing equipment, lack of employee training, and poor computer system controls for master batch records.

## 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)
- [483 - 2018-08-20](https://www.globalkeysolutions.net/records/483/pharmasol-corporation/1def15f9-dbc9-4aa5-9c61-7173481cde23)
- [483 - 2022-02-10](https://www.globalkeysolutions.net/records/483/pharmasol-corporation/6f83e99a-c5ff-4088-bf2b-f75f2264696f)

## Related Officers

- [Deputy Director](https://www.globalkeysolutions.net/people/lori-m-newman/a0e448e4-11ba-4095-b879-feabb8750b3f)
- [M.S., Consumer Safety Officer at FDA](https://www.globalkeysolutions.net/people/daniel-l-zheng/5e3d993f-654e-4d40-a2c8-69c5e396499f)
- [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