FDA EIR - Patheon Manufacturing Services LLC - July 17, 2018

An FDA inspection of Patheon Manufacturing Services, LLC, a contract manufacturer in Greenville, NC, was conducted from July 11 to July 17, 2018. The inspection, aligned with the Compliance Program Guidance Manual 7345.848 for Biological Products (CBER), focused on current Good Manufacturing Practices (cGMP) for filling and packaging a multi-dose vial product. The inspection identified two main deficiencies, resulting in the issuance of a Form FDA-483, Inspectional Observations.

The first observation cited deficient complaint handling. A product technical complaint regarding leaking vials for a specific lot was improperly classified, leading to a lack of a full investigation, as it was erroneously deemed a repeat of a prior 'low fill' complaint for the same lot. The second deficiency involved incomplete batch production records, specifically the omission of critical line clearance documentation in several records, raising concerns about proper assurance of operations. Patheon acknowledged the complaint handling issue and commenced a targeted investigation. For the batch record discrepancy, the firm indicated an ongoing effort to develop a new standard operating procedure, though prior year deficiencies were noted without evidence of full correction for current batches.