FDA WARNING_LETTER - Apnea Sciences Inc - December 06, 2012

On May 9, 2013, the FDA issued a Warning Letter to Apnea Sciences Inc. following an inspection from November 27 to December 6, 2012. The firm, a specification developer and own-label distributor of ApneaRx and SnoreRx dental guards for snoring and sleep apnea, was found to be in violation of current good manufacturing practice (cGMP) requirements of the Quality System regulation (21 CFR Part 820), rendering their devices adulterated.

Key violations include: 1. **Failure to establish and maintain adequate CAPA procedures (21 CFR 820.100(a))**: No written CAPA procedures or records of analyzing quality data to determine CAPA needs. 2. **Inadequate complaint handling (21 CFR 820.198(c))**: Failure to review, evaluate, and investigate complaints, including a significant percentage of returned devices with issues like pain, difficulty breathing, and device malfunction. 3. **Lack of Medical Device Reporting (MDR) procedures (21 CFR 803.17)**: No written MDR procedures, and complaints were not evaluated for potential MDR reports. 4. **Absence of complaint receiving/evaluation procedures (21 CFR 820.198(a))**: No written procedures for receiving, reviewing, and evaluating consumer complaints. 5.