FDA WARNING_LETTER - So-Low Environmental Equipment Co. Inc. - April 17, 2013

An FDA inspection of So-Low Environmental Equipment Co., Inc. from April 9-17, 2013, revealed that their ultra-low temperature freezers for medical applications are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's May 1, 2013, response to the FDA 483 was deemed inadequate.

Key violations include: - **Corrective and Preventive Actions (CAPA):** Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)), with no documented review of data sources or proper use of the CAPA log. - **Complaint Handling:** Inadequate maintenance of complaint files and failure to review/evaluate all complaints for investigation necessity (21 CFR 820.198(a), (b)), with missing documentation and lack of review for numerous complaints. - **Training:** Failure to establish training procedures and ensure personnel are adequately trained (21 CFR 820.25(b)), evidenced by incomplete competency forms and lack of quality system training. - **Organizational Structure:** Inadequate organizational structure to ensure device compliance (21 CFR 820.20(b)), lacking a dedicated quality department or personnel. - **