Genzyme Ireland Limited

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to ensure that laboratory records include complete data derived from all tests necessary to assure compliance with established specifications and standards, as required by 21 CFR 211.194(a). For example: i. Multiple non-viable particulate excursions and repeated (b)(4) test failures across multiple batches present in instrument histories were not documented in laboratory records for review and investigation. (b)(4) testing was repeated up to 11 times without documentation.

Passage 2

On multiple occasions, the number of active air monitoring samples documented in environmental monitoring records was not directly traceable to the instrument histories of the specific air samplers identified on those records. Additionally, logbooks documenting when environmental monitoring was performed were not always consistent with cleanroom entry and exit times for personnel performing the sampling. Consequently, these records could not be relied upon to accurately document environmental monitoring activities, as accurate records are critical to providing reliable evidence of environmental control.

Passage 3

Your laboratory records were incomplete because quality control personnel used uncontrolled Review Checklists to unofficially document laboratory record reviews, which were subsequently discarded. Additionally, updates to your records were not always traceable or attributable to a specific person.

Passage 4

Failure to thoroughly investigate any unexplained discrepancy, or the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed, as required by 21 CFR 211.192. For example, at the time of the inspection, your firm cancelled numerous deviations without investigating the root cause or assessing product impact.