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Pharmaceuticals / Inspections and Audits

Massachusetts Drugmaker Receives 483

Oct. 30, 2018

The FDA issued Berkshire Sterile Manufacturing a Form 483, citing issues encountered during an inspection at the firm’s Lee, Massachusetts, facility.

The March 26 to April 13 inspection revealed that the company failed to conduct studies to gauge the effectiveness of disinfectants used in its cleanroom and on various surfaces. The firm also neglected to conduct studies for cleaning agent contact times, relying solely on manufacturer recommendations.

A Berkshire spokesperson said the company has resolved the issues to the FDA’s satisfaction and the facility has performed the cleaning efficacy study.

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