# FDA 483 - Alyk Inc. - May 20, 2022

Source: https://www.globalkeysolutions.net/records/483/alyk-inc/828f1e6b-3f32-481f-9aed-3bc00a57ff0c

> FDA 483 for Alyk Inc. on May 20, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alyk Inc.
- Inspection Date: 2022-05-20
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Alyk Inc., a medical device manufacturer and importer in New York, NY, was inspected by the FDA. The inspection revealed one observation concerning the firm's failure to maintain written Medical Device Reporting (MDR) procedures. Specifically, the firm lacked electronic MDR procedures and an Electronic Submissions Gateway account for reporting serious injuries and deaths.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.globalkeysolutions.net/companies/alyk-inc/250bbaf2-598a-4255-aa7c-e09c9f971390

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961