Dannik LLCAugust 12, 2022

FDA 483 - Dannik LLC - August 12, 2022

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Dannik LLC

Record Details

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.

Company: Dannik LLC
Inspection Date: August 12, 2022
Product Type: Device
Office: Chicago District Office
Person: Shafiq S. Ahadi (Investigator)

Open in Dashboard

ID · 624fbd7f-a6d9-4832-91af-9a3b650053a4