Brazilian Devicemaker Warned Over Design Change Documentation

Greiner Bio One Brasil Produtos ran afoul of the FDA after documenting design changes in informal meetings with informal notes, a recent warning letter shows.

During a Jan. 13-16 inspection of its Americana, Brazil, facility, the investigator reviewed a labeling change and found Greiner did not have a formal procedure specifying change activities. The company, which makes Vacuette blood collection tubes, also lacked a formal procedure for verification and documentation of the change activities’ completion, according to the Aug. 8 letter.

“Available procedures including the change control procedure, change control form, and change log form do not address timing of change implementation or effect on existing stock,” the letter says. Applicable design changes were being managed and documented using “informal meetings and … uncontrolled meeting notes,” the letter adds.

Greiner’s quality manager indicated that the local procedure for design change control activities does not specify local methods to track or document required change implementation activities, according to the letter.

The investigator also found that Greiner did not adequately document inspection requirements for rubber stoppers, and its incoming acceptance documentation lacked data or certificates of conformance showing the prescribed acceptance testing protocol was performed.

The warning letter also points out that the Vacuette collection tubes have specific requirements in the product labeling for their shelf-life and maximum trace element content. However, an FDA review of batch records revealed that Greiner had not performed continued testing in support of the shelf-life stability requirements or maximum permissible trace element content.

Greiner also came under FDA scrutiny for failing to measure its quality audits against agency requirements. The company’s internal audit criteria did not identify any requirements from the Quality System Regulation or other applicable FDA regulations in the applicable internal audit procedures or internal audit plans, the warning letter says.

Company officials acknowledged that “the 2013 quality audit plan had not explicitly required auditing against any FDA requirements,” the letter adds.

Manfred Abel, quality system and regulatory affairs manager, said Greiner takes the warning letter seriously and is working with the FDA to resolve and correct the deviations.

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