FDA WARNING_LETTER - TERRAGENE S.A. - June 09, 2023

On November 1, 2023, the FDA issued a Warning Letter to Mr. Esteban Lombardia of Ruta Nacional N9 Km 280, CP 2130, Parque Industrial Micropi 2130 Alvear Santa Fe Argentina, following an inspection from June 6-9, 2023. The firm manufactures and distributes Biological and Chemical Sterilization Process Indicator Systems.

The inspection revealed the devices are adulterated under 21 U.S.C. § 351(h) because manufacturing methods, facilities, or controls do not conform to the Quality System regulation (21 CFR Part 820).

Violations include: 1. Failure to establish adequate procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a)(b)). The firm's procedure lacks definitive timelines for complaint evaluation and complainant contact, and does not describe the process for determining investigation necessity or MDR reportability. The firm could not provide documentation for reviewing or evaluating 96 U.S. market complaints received between June 21, 2021, and June 9, 2023. The firm's responses were deemed inadequate, lacking the new "Complaint Handling SOP" and retrospective review analysis. 2. Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures (21 CFR