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Pharmaceuticals / Inspections and Audits

U.K. Drugmaker Hit for Having No Quality Unit

Feb. 1, 2018

The FDA served Sacutia Healthcare a Form 483 after discovering the company had no quality unit at its St. Helen’s, United Kingdom facility.

An inspection by the agency in September revealed that the facility lacked written procedures for manufacturing or testing operations, and it failed to properly investigate discrepancies, changes in product quality, complaints, and failures to meet product specifications.

Incoming components used in manufacturing at the facility were not tested to ensure they met quality, safety, identity, strength and purity standards. The firm also failed to fully document batch manufacturing operations such as the actual amount of material weighed and dispensed, manufacturing times and temperatures, and lot numbers of ingredient lots used in manufacturing.

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