FDA 483 - TERRAGENE S.A. - June 09, 2023

An FDA inspection of TERRAGENE S.A., a medical device manufacturer in Alvear, Santa Fe, Argentina, conducted from June 6-9, 2023, identified significant compliance deficiencies, resulting in a Form FDA 483 with three key observations. The primary issues revolved around inadequate quality system controls and a lack of familiarity with U.S. regulatory requirements.

Specifically, the company's procedures for receiving, reviewing, and evaluating customer complaints were found insufficient. This included a failure to ensure the receipt of complaints from the U.S. market, uniform evaluation, and proper assessment for Medical Device Reporting (MDR) obligations under 21 CFR Part 803. Furthermore, TERRAGENE S.A. had not developed, maintained, or implemented required written procedures for Medical Device Reporting (21 CFR Part 803), despite manufacturing devices for the U.S. market.

Finally, the inspection revealed that personnel lacked the necessary background, training, and experience concerning U.S. FDA regulations, including 21 CFR Part 803 (MDR), 21 CFR Part 807 (Establishment Registration and Device Listing), and 21 CFR Part 820 (Quality System Regulation).

TERRAGENE S.A. has committed to addressing these observations, which will necessitate implementing comprehensive corrective actions to establish robust complaint handling and MDR procedures, and to ensure thorough training on relevant U.S. medical device regulations.