# FDA 483 - Pharmasol Corporation - June 14, 2021

Source: https://www.keypedia.com/records/483/pharmasol-corporation/2f82c380-05ca-4443-971f-5a7cedb840c3

> 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: Division of Northeast Imports 
- Summary: During an FDA inspection from June 7-14, 2021, Pharmasol Corporation, a human drug contract manufacturer in Stoughton, MA, received one observation. The observation noted a failure to properly inspect and release components, specifically actuators, by the quality control unit prior to their use in drug product manufacturing. This indicates a significant lapse in the firm's quality control procedures for incoming materials.

## Related Documents

- [WARNING_LETTER - 2018-08-20](https://www.keypedia.com/records/warning_letter/pharmasol-corporation/b2eab70e-ff24-4ad1-9212-aab107273001)

## Related Officers

- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.keypedia.com/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)
- [Deputy Director](https://www.keypedia.com/people/lori-m-newman/a0e448e4-11ba-4095-b879-feabb8750b3f)

Company: https://www.keypedia.com/companies/pharmasol-corporation/0e41c5e9-84c1-4f06-b680-c34a2a028f5f

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94