FDA WARNING_LETTER - Andersen Sterilizers Inc - November 29, 2011

During an inspection from November 11-29, 2011, the FDA found that Andersen Sterilizers, Inc. in Haw River, NC, manufactures ethylene oxide sterilizers and accessories that are adulterated and misbranded. The products are adulterated because the firm lacks approved Premarket Approval (PMA) applications or Investigational Device Exemptions. They are misbranded due to failure to submit 510(k) premarket notifications and failure to fulfill annual establishment registration and device listing requirements for fiscal year 2011, as mandated by Section 510(p) of the Act.

Additionally, the inspection revealed significant quality system deficiencies, including: 1. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a)). Complaint files lacked adequate documentation, and reported customer dissatisfaction, including MDR-reportable events like EO spills and patient injury, were not properly advanced or investigated. 2. Failure to review and evaluate all complaints to determine investigation necessity, and to document reasons for not investigating (21 CFR 820.198(b)). Examples included malfunctions without documented cause or preventative actions. 3. Failure to adequately control production processes to ensure device conformity (21 CFR 820.70(a)). Specifically, procedures for handling under-filled ampoules lacked sufficient instructions for correction or improvement