FDA WARNING_LETTER - Frontier Medical Products - July 09, 2010

On September 1, 2010, the FDA issued a Warning Letter to Frontier Medical Products following an inspection from June 7 to July 9, 2010. The inspection revealed that the firm's blood pressure cuffs, classified as medical devices, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: - Failure to establish procedures for design changes (21 CFR 820.30(i)), evidenced by an unverified/unvalidated change in blood pressure cuff manufacturing in April 2010, and a non-existent "Procedure for Design Change" (SOP 1244-000). - Failure to implement corrective and preventive actions (21 CFR 820.100(a)), with the "Procedure for Risk Management" (PP1227-000) not being followed and required CAPA forms (F037) not existing. - Failure to maintain a complaint procedure (21 CFR 820.198(a)), as a March 24, 2010, complaint was not processed per "Procedure for Complaint Processing" (PP1218-0