Zander Scientific, Inc. – FDA Warning Letter, Jul 14, 2010

On October 5, 2010, the FDA issued a Warning Letter to Zander Scientific, Inc. dba Zander IVF, Inc. following an inspection from July 12-14, 2010. The inspection determined that the firm is a specification developer of the zIVF-AIRe™ 100C Photo-Catalytic Air Purifier, classified as a medical device. The device was found to be 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 include: 1. Failure to establish and maintain design control procedures (21 CFR 820.30(a)(1)), lacking written procedures and documentation for labeling requirements. 2. Failure to establish and maintain corrective and preventive action procedures (21 CFR 820.100(a)), lacking a written procedure. 3. Failure to establish and maintain complaint procedures and files (21 CFR 820.198(a)), lacking written procedures and maintaining complaint files. 4. Failure to establish and maintain procedures for ensuring purchased products and services conform to requirements (21 CFR 820.50), lacking written procedures. 5. Failure