FDA EIR - Sarstedt Inc - July 02, 2018

Sarstedt Inc., a medical device manufacturer in Newton, NC, underwent an FDA inspection from June 28 to July 2, 2018. This Quality System Inspectional Techniques (QSIT) Level I inspection, conducted under Compliance Program 7382.845, focused on the firm's Corrective and Preventive Action (CAPA) and Production and Process Control subsystems for Class II S-Monovette blood collection tubes.

The inspection identified five significant deficiencies on Form FDA-483. These included inadequate documentation of labels in Device History Records (DHRs), failure to identify affected documents in change records, DHRs not fully demonstrating manufacturing in accordance with device master records and 21 CFR Part 820 (specifically regarding device disposition), and poorly established CAPA procedures (e.g., failure to address malfunctioning equipment and assess impact on affected lots). Additionally, certain Quality System documents were issued without prior review and approval by designated personnel.

Sarstedt Inc.'s management acknowledged these observations and committed to implementing the necessary corrections. The FDA cautioned that these findings are not a final agency determination but could result in legal sanctions if not adequately addressed. Management was also advised to improve complaint investigations by including root cause determination and DHR reviews, and to submit Medical Device Reports (MDRs) electronically.