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# FDA Hits Pharmasol with Warning Letter on GMPs
- URL: https://www.fdaweb.com/fda-hits-pharmasol-with-warning-letter-on-gmps/
- Published: 2019-06-07T12:00:00.000Z
- Updated: 2026-09-15T01:31:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144287

FDA has posted a 3/14 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pharmasol-corporation-570727-03142019?ref=fdaweb.com) to Pharmasol after conducting two 8/2018 facility inspections at South Easton, MA and Stoughton, MA, and citing significant GMP violations at both. At both facilities, FDA said, the firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications.

FDA’s letter criticized Pharmasol’s quality unit authority. **“**Your inspectional history indicates that your quality unit is not able to fully exercise its authority and/or responsibilities,” it said. “Your firm must provide the quality unit with the appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality.”

Additionally, the Warning Letter noted that repeat observations are being cited at the South Easton facility. It said that similar GMP observations were documented in previous inspections in 2013, 2014; and 2015\. FDA recommended that the company hire a GMP consultant to help it meet GMP requirements, particularly because it failed to correct the repeat violations.