New Life Generation, Inc. – FDA Warning Letter, Aug 10, 2011

On October 17, 2011, the FDA issued a Warning Letter to New Life Generation, Inc. following an inspection from July 19 to August 10, 2011. The inspection revealed significant deviations from 21 CFR Part 1271 for human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Key violations include: 1. **Failure to maintain concurrent records [21 CFR 1271.270(a)]**: Discrepancies were found between documented responses on Medical Social History Interview forms and actual interviews. Screeners omitted or partially asked questions regarding communicable disease risk factors, yet documented full responses. Additionally, changes to records lacked documentation of the source of new information. 2. **Failure to screen donors by reviewing relevant medical records [21 CFR 1271.75(a)]**: Available medical records, such as physician records and hospital records, were not obtained and reviewed prior to donor eligibility determinations, potentially leading to improper evaluation for conditions like plasma dilution. 3. **Failure to document HCT/P disposition for tracking [21 CFR 1271.290(e)]**: Several skin grafts were not listed on distributed HCT/P lists or quarantine logs, lacking documentation of their disposition. 4. **Failure to establish and maintain a quality program [21 CFR