FDA WARNING_LETTER - Hiossen Inc. - May 16, 2012

The FDA issued a Warning Letter to Hiossen, Inc. following an inspection from April 30 to May 16, 2012, at their Fairless Hills, PA facility, which manufactures dental implant fixture sets. The inspection determined that the firm's devices are adulterated under Section 501(h) of the Federal Food, Drug and Cosmetic Act, as their manufacturing methods and controls do not conform to the Quality System (QS) Regulation (21 CFR Part 820). Key violations identified include management's failure to ensure the quality policy is understood and implemented (21 CFR § 820.20(a)), inadequate procedures for receiving and evaluating complaints (21 CFR § 820.198(a)), insufficient documentation of process validation activities (21 CFR § 820.75(a)), and failure to establish design control procedures and adequately document design validation/verification in the design history file (21 CFR § 820.30(g) and (f)). The firm's submitted corrective actions were acknowledged but lacked supporting documentation and require further evaluation. Hiossen, Inc. must promptly correct these violations and respond within fifteen working days with specific corrective steps, prevention plans, and a timetable. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, denial of premarket approvals, and refusal of Certificates to Foreign Governments. The letter emphasizes the firm's responsibility to investigate and correct all underlying causes of the identified systemic quality system deficiencies.