FDA 483 - Dannik LLC - August 12, 2022

Dannik, a medical device manufacturer in Orlando, FL, received an FDA Form 483 citing significant quality system deficiencies. The firm failed to submit Medical Device Reports (MDRs) within the required 30-day timeframe and did not promptly review and investigate MDR-reportable complaints. Additionally, Dannik lacked established procedures for corrective and preventive actions to address recurring nonconforming product issues.