FDA WARNING_LETTER - Fall Prevention Technologies - May 21, 2008

An FDA inspection of Fall Prevention Technologies in Kettering, Ohio, from May 5-21, 2008, revealed that their Balanceback iVNG device was manufactured under conditions not conforming to the Quality System (QS) regulation (21 CFR Part 820), rendering it adulterated per 21 U.S.C. § 351(h). The firm received a Form FDA 483 with multiple observations. Key violations included management's failure to ensure an adequate quality system (21 CFR § 820.20), inadequate corrective and preventive action (CAPA) procedures and implementation (21 CFR § 820.100), and insufficient complaint handling (21 CFR § 820.198). Further deficiencies involved service reports lacking test data (21 CFR § 820.200(d)(6)), improper release of finished devices (21 CFR § 820.80(d)(2)), failure to establish a Device Master Record (21 CFR § 820.181), inadequate design control procedures and implementation (21 CFR § 820.30), and poor record storage practices (21 CFR § 820.180). The FDA reviewed the firm's responses but found them inadequate due to incomplete actions and extended timelines for corrective measures, some stretching into late 2008 and early 2009. The letter warns of potential regulatory actions, including seizure, injunction, civil money penalties, and impacts on federal contracts, premarket approvals, and Certificates to Foreign Governments if violations are not promptly corrected. The firm must provide a written response within fifteen working days detailing corrective actions and explaining any delays.