FDA EIR - Charles River Laboratories Cleveland, Inc. - February 19, 2020

An FDA inspection was conducted at Charles River Laboratories Cleveland, INC., a contract laboratory located in Cleveland, OH, from February 18 to February 19, 2020. This comprehensive inspection, performed under the FDA's 'Drug Manufacturing Inspections' program, covered the firm's systems and operations related to contract laboratory testing. Charles River Laboratories Cleveland provides essential services such as bioassay, potency, and stability-indicating testing for drug products and drug substances, including a specific GMP bioassay for cystic fibrosis transmembrane conductance regulator (CFTR).

The inspection aimed to assess the firm's adherence to relevant regulatory standards for drug manufacturing support. A significant finding of this review was the absence of any significant observations or issues. Consequently, no Form FDA 483, 'Inspectional Observations,' was issued to the company. The facility appeared well-maintained and orderly during the walkthrough. Furthermore, the FDA investigator reviewed the firm's handling of Out-of-Tolerance (OOT) and Out-of-Specification (OOS) investigations, as well as deviations, noting that these processes were being managed effectively, with timely identification of root causes and communication to clients.

Given that no deficiencies or violations were identified, no specific corrective actions or regulatory requirements were mandated by the FDA following this inspection. The inspection concluded with a 'No Action Indicated' classification, signifying satisfactory compliance with applicable regulations.