Terragene S.A.

Warning LetterClosed

Mr. Esteban Lombardia CEO Terragene S.A. Ruta Nacional N9 Km 280, CP 2130, Parque Industrial Micropi 2130 Alvear Santa Fe ArgentinaFEI 3013145340Issued Nov 1, 2023Center for Devices and Radiological Health

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3013145340.

Letter Details

Firm: Terragene S.A.
Location: Mr. Esteban Lombardia CEO Terragene S.A. Ruta Nacional N9 Km 280, CP 2130, Parque Industrial Micropi 2130 Alvear Santa Fe Argentina
FEI Number: 3013145340
Country: Argentina
Issue Date: November 01, 2023
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Closed
Closeout Letter: June 28, 2024

Summary

Terragene S.A., an Argentina-based manufacturer of Biological and Chemical Sterilization Process Indicator Systems, was found to produce adulterated medical devices that failed to comply with current good manufacturing practice (CGMP) requirements under 21 CFR Part 820. The FDA inspection conducted in June 2023 identified failures to establish adequate complaint handling procedures, specifically noting that the firm's procedures did not ensure complaints were received, reviewed, and evaluated in a uniform and timely manner as required by 21 CFR 820.198(a)(b). The company's violations stemmed from deficient manufacturing, packing, storage, or installation controls that did not meet Quality System regulation standards.