Aerscher Diagnostics, LLC – FDA Warning Letter, Jan 19, 2011

On June 28, 2011, the FDA issued a Warning Letter to Aerscher Diagnostics, LLC, following a January 18-19, 2011 inspection. The inspection revealed that the firm's fecal/gastric occult blood screening tests are adulterated under 21 U.S.C. § 351(h) because manufacturing methods, facilities, or controls do not conform to Quality System (QS) regulation (21 CFR Part 820).

The FDA found eight significant QS regulation violations, including: 1. Failure to establish and maintain corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)), lacking requirements for data analysis, investigation, verification, and dissemination of information. 2. Failure to establish and maintain adequate complaint handling procedures (21 CFR 820.198(a)), specifically regarding timely processing and evaluation for Medical Device Reporting (MDR) requirements. 3. Failure to establish and maintain procedures for controlling nonconforming product (21 CFR 820.90(a)), lacking identification, evaluation, segregation, and disposition. 4. Failure to establish and maintain process control procedures (21 CFR 820.70(a)), with no documented instructions or SOPs for device production. 5. Failure to establish and maintain equipment maintenance