# FDA 483 - Aerolase Corp. - May 20, 2021

Source: https://www.globalkeysolutions.net/records/483/aerolase-corp/55646690-8312-4fa0-b6cd-205b3408a0e6

> FDA 483 for Aerolase Corp. on May 20, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aerolase Corp.
- Inspection Date: 2021-05-20
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Aerolase Corp. in Tarrytown, NY, from May 11-20, 2021, revealed significant deficiencies in quality system compliance. Observations included the lack of proper certification labels on finished laser devices, inadequate maintenance of device history records, and insufficient corrective and preventive action procedures, particularly regarding effectiveness checks.

## Related Documents

- [483 - 2019-08-08](https://www.globalkeysolutions.net/records/483/aerolase-corp/2da05363-7fd8-44b3-824c-5188998354e4)

## Related Officers

- [Andrew J. Garufi](https://www.globalkeysolutions.net/people/andrew-j-garufi/567f6aaa-f6f2-45a3-9a58-80b33f3ad021)

Company: https://www.globalkeysolutions.net/companies/aerolase-corp/b6d48953-2385-4a88-b4cc-a8b8cb497479

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