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# Hopkinton Drug Notice of Violation
- URL: https://www.fdaweb.com/hopkinton-drug-notice-of-violation/
- Published: 2022-01-27T12:00:00.000Z
- Updated: 2026-09-14T17:30:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151022

FDA has just released a 9/16/2021 Notice of Violation issued to Hopkinton Drug, a Hopkinton, MA, sterile drug producer, following an 8/25-11/2/20 inspection that identified deficiencies in the company’s practices for producing drug products that put patients at risk. The [letter](http://www.fda.gov/media/155703/download?ref=fdaweb.com) says the inspection observations were: 

- non-microbial contamination was observed in the firm’s production area; and
- the firm handled hazardous drug products without providing adequate containment, segregation, or cleaning of work surfaces and utensils to prevent cross-contamination.

The letter says FDA could not fully evaluate the adequacy of some of Hopkinton’s proposed actions to correct the violations because it did not submit sufficient information or documentation.

Hopkinton was told to respond with a list of specific steps it has taken to address the violations, with documentation of each step and a timetable for completing the actions.