FDA WARNING_LETTER - BioSafe America Corporation - June 27, 2008

The FDA issued a Warning Letter to Bio-Safe America Corporation following an inspection from June 2-27, 2008, at their Santa Ana, California facility. The firm manufactures a laminar flow unidirectional clean air system, which FDA determined to be a medical device. The inspection revealed the device is adulterated under 21 U.S.C. 351(h) due to significant non-conformity with the Quality System (QS) regulation (21 CFR Part 820). Violations include a complete lack of a quality system, no established quality policy, and no procedures for quality audits, document controls, installation, servicing, complaint handling, corrective and preventive actions (CAPA), purchasing controls, or acceptance activities. Furthermore, the device is misbranded under 21 U.S.C. 352(t)(2) for failing to develop a written Medical Device Reporting (MDR) procedure (21 CFR 803.17). It is also adulterated under 21 U.S.C. 351(f)(1)(B) because the firm lacks an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) application. Additionally, the device is misbranded under 21 U.S.C. 352(o) for failure to submit a 510(k) premarket notification and for being manufactured in an unregistered establishment, not included in a required list. The FDA requires prompt corrective action within fifteen working days, including a detailed plan and documentation, to prevent further regulatory actions such as seizure, injunction, or civil money penalties, and to avoid impacts on contract awards or device approvals.