FDA WARNING_LETTER - DeRoyal Cientifica De Latinoamerica S.R.L. - February 28, 2013

On February 25-28, 2013, an FDA inspection of DeRoyal Cientifica De Latinoamerica S.R.L. in La Aurora, Heredia, Costa Rica, revealed that their electrosurgical cutting and coagulation accessory and esophageal stethoscope devices are misbranded. The firm failed to furnish required information under the Medical Device Reporting (MDR) Regulation (21 CFR Part 803).

Significant violations include: 1. Failure to document explanations for missing information on FDA Form 3500A in MDR event files (e.g., MDR# 9613793-2011-00001). 2. Failure to adequately develop, maintain, and implement written MDR procedures (21 CFR 803.17(a)). The procedure "Medical Device Problem Reporting," CORP.PRC.004, Rev. J, lacked definitions for key terms like "become aware" and "caused or contributed," and did not provide instructions for obtaining, completing, or submitting FDA 3500A forms.

Additionally, the inspection identified quality system deficiencies under 21 CFR Part 820 (Quality System regulation): 1. Failure to establish and maintain procedures for corrective and preventive action (21 CFR 820.100(a)), with issues like incomplete verification of effectiveness, inadequate evaluation of impact on devices, and missing documentation