FDA WARNING_LETTER - Cheen Houng Enterprise Co., Ltd. - August 08, 2013

On November 14, 2013, the FDA issued a Warning Letter to Cheen Houng Enterprise Co., Ltd. following an inspection from August 5-8, 2013, in Taipei (Shulin), Taiwan. The inspection found that the firm's disposable/reusable resuscitators, water traps, pediatric stretchers, and face cradles were adulterated under section 501(h) of the Act, as their manufacturing methods, facilities, or controls did not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Process Validation (21 CFR 820.75(a)):** Failure to adequately validate the (b)(4) process for critical resuscitator components, lacking high assurance, approved protocols, operational qualifications, and documented parameter settings. 2. **CAPA Procedures (21 CFR 820.100(a)):** Absence of established and maintained procedures for corrective and preventive actions, with quality data not formally reviewed statistically and CAPAs lacking objective evidence. 3. **Nonconforming Product (21 CFR 820.90(b)(1)):** Failure to establish procedures for and document the disposition of nonconforming product, specifically for (b)(4) resuscitator pieces. 4. **Design History File (