FDA EIR - Halkey Roberts Corp - August 26, 2015

An FDA inspection of Halkey Roberts Corp, a medical device manufacturer in Saint Petersburg, FL, was conducted from August 19-26, 2015. The inspection, carried out under the regulatory framework for medical device manufacturers (CPGM 7382.845), focused on the firm's quality system, particularly Corrective and Preventive Actions and Production and Process Controls. The company manufactures Robertsite® Needlefree Injection Site Valves.

The inspection identified two primary violations, documented on an FDA Form 483. First, the company failed to fully implement its written procedures for accepting incoming products, specifically regarding the modification of sampling inspection levels when unacceptable components were identified, contrary to 21 CFR 820.80(b). Second, procedures for controlling non-conforming products were inadequate. The firm's written procedures did not require documentation of the description or evaluation of nonconforming products when entire lots were not rejected or when products were scrapped, as required by 21 CFR 820.90(a). Records lacked such details for specific nonconforming Swabable Stem components.

Mr. Alan D. King, Vice President of Operations, committed to correcting these deficiencies and submitting a formal written response to the FDA within fifteen business days. No samples were collected, and there were no refusals during the inspection.