FDA WARNING_LETTER - Brant-Wald Surgicals Inc - August 11, 2010
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On October 1, 2010, the FDA issued a Warning Letter to Brant-Wald Surgicals, Inc. following an inspection from August 9-11, 2010. The inspection revealed that the firm's sterile Trans-Urethral-Resection (TUR) aprons are adulterated under Section 501(h) of the Act, as manufacturing methods, facilities, or controls do not conform to the Quality System regulation (21 CFR Part 820).
Key violations include: 1. **Failure to implement CAPA (21 CFR 820.100(b)):** A dose audit of TUR aprons failed sterility specifications in March-April 2010, but aprons from the affected lot were distributed without investigation or corrective action. The FDA determined this poses a risk of surgical site infection, sepsis, and prolonged hospital stays. The proposed CAPA SOP was inadequate, lacking responsibility for approval and addressing nonconforming products in distribution. 2. **Failure to monitor and control validated processes (21 CFR 820.75(b)):** No data supports the five-year expiration date on TUR Apron labels, and the firm did not address products currently in distribution. 3. **Incomplete Device History Records (DHR) (21 CFR 820.184(e)):** DHRs lacked copies of labeling
ID · 4edd3965-820a-44e9-8fdf-372843b70e4c
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