FDA Warns Lonza Over Production, Validation, Cleaning Procedures

May 19, 2017

The FDA warned device manufacturer Lonza over inadequate validation, CAPA procedures, and other violations at its Walkersville, Md., facility.

The agency inspected the facility in late January and early February and issued a Form 483, but found the company’s response to be inadequate.

In a warning letter, the FDA noted the facility lacked an established master plan for validation processes involving cleanroom operations, cleaning validations and HEPA filter certifications. It also lacked a cleanroom risk assessment procedure.

Specifically, according to the warning letter, the facility had no requirements in its procedure for qualifying a clean room.

The facility also failed to use established methods for product sterility testing. It used a surrogate sterility test with no representative sample of the batch, which was not sufficiently sensitive.

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