FDA EIR - Waters Corporation - June 13, 2018

This FDA Establishment Inspection Report details a routine, pre-announced medical device inspection of Waters Corporation's Milford, MA facility, conducted from June 11 to June 13, 2018. The inspection was performed under Compliance Program 7382.845A, Medical Device Level I (Abbreviated) Inspection, and focused on the company's manufacturing of various medical devices, including Class I and Class II products like Tacrolimus Enzyme Immunoassays and HPLC instrumentation. Key areas reviewed included Management Controls, Corrective and Preventive Action (CAPA), and Production and Process Controls, along with purchasing controls, complaints, and recall procedures.

Significantly, the inspection concluded without the issuance of an FDA Form 483, indicating no formal regulatory violations or deficiencies were identified. The report notes thorough reviews of quality policies, internal audits, complaint handling, nonconformance records, production processes, calibration, and device history records, all of which were found to be compliant or without irregularities. A minor recommendation was made for the firm to contact the District Office for concurrence on future field actions to ensure adherence to 21 CFR 806.20. Overall, Waters Corporation demonstrated a robust quality system, and all personnel were cooperative, providing requested documentation readily.