FDA WARNING_LETTER - GF Health Products, Inc. - September 23, 2011

On August 29, 2011, through September 23, 2011, an FDA inspection of GF Health Products, Inc./d.b.a. Basic American Metal Products, a manufacturer of electrical-powered and manual beds, revealed adulterated devices due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Violations included: 1. **Failure to establish adequate CAPA procedures (21 CFR 820.100(a))**: No root cause analysis for CAPAs 1017, 1018, 1019; no review of original data source in effectiveness checks for CAPAs 1016, 1009; and no independent audits for CAPAs 1015, 1010, 1011. 2. **Failure to include required information in complaint investigation records (21 CFR 820.198(e))**: Dates and/or results of investigations were not documented for complaints 16669, 10468, 15149, and 9759. 3. **Failure to establish procedures for finished device acceptance (21 CFR 820.80(d))**: No procedure