FDA Warns Lonza’s Class II Device Manufacturing Site

Regulatory NewsRegulatory News | 09 May 2017 |  By 

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 21 April to Lonza’s contract manufacturing site for Class II devices in Walkersville, MD.

The four observations from the inspection conducted from 18 January 2017 through 6 February 2017 deal with validation failures, the site’s failure to develop, conduct, control and monitor production processes, corrective and preventive action (CAPA) failures and a failure to adequately establish procedures to control environmental conditions.

While acknowledging Lonza’s responses to observations cited in a previous Form 483, FDA also seeks further remediation in some cases.

For instance, FDA found that the site’s validation master plan, covering cleaning validations, cleanroom qualifications and HEPA filter certifications, “is not adequately established.”

FDA said: “There are no requirements in your master validation procedure for qualifying a clean room. There should be requirements in this procedure for how you are going to comply with the ISO 14644 standard and your quality system.”

The agency also called out the firm for failing to test numerous product lots for sterility based on USP <71> or an equivalent method.

“You instead used a surrogate sterility test that lacks a representative sample of the batch and is insufficiently sensitive. We acknowledge that your firm commits to testing sterility of finished products based on USP <71> in the future. It should be noted, however, that a passing sterility test alone is insufficient to support release of products unless the manufacturing operation is designed to robustly and reproducibly assure batch sterility,” FDA inspectors said.

Lonza did not offer any statement in response to a request for comment. The site employs 524 people and also manufactures sterile cell therapies, among other medical products.

Warning Letter


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