# FDA 483 - Pharmasol Corporation - August 20, 2018

Source: https://www.keypedia.com/records/483/pharmasol-corporation/1def15f9-dbc9-4aa5-9c61-7173481cde23

> FDA 483 for Pharmasol Corporation on August 20, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmasol Corporation
- Inspection Date: 2018-08-20
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: Pharmasol Corporation in South Easton, MA, a human drug manufacturer, received a Form FDA 483 with nine observations highlighting significant deficiencies in its quality system and manufacturing practices. Repeated observations from previous inspections indicate a persistent failure to adequately investigate discrepancies, follow quality control procedures, maintain stability testing programs, and ensure facility and equipment cleanliness. The findings suggest a systemic lack of control over critical processes, potentially impacting drug product quality and patient safety.

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## Related Officers

- [Program Division Director/District Director](https://www.keypedia.com/people/jonathan-g-matrisciano/17e5bce2-75a6-4182-925d-b94b42763dd2)
- [Sean R. Marcissin](https://www.keypedia.com/people/sean-r-marcissin/3cee7868-b7ea-477b-add3-218b9e7c5285)

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

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