# FDA 483 - Dannik  LLC - August 12, 2022

Source: https://www.globalkeysolutions.net/records/483/dannik-llc/624fbd7f-a6d9-4832-91af-9a3b650053a4

> FDA 483 for Dannik  LLC on August 12, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dannik  LLC
- Inspection Date: 2022-08-12
- Product Type: device
- Office Name: Chicago District Office
- Summary: 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.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/shafiq-s-ahadi/dd146b0a-ca1c-4052-8f50-4d68e14ad73f)

Company: https://www.globalkeysolutions.net/companies/dannik-llc/84f40791-f61b-4b7a-ad32-d237a39a7bb4

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669