# FDA 483 - Sky Medical Supplies and Equipments, LLC - September 17, 2021

Source: https://www.keypedia.com/records/483/sky-medical-supplies-and-equipments-llc/c34c9800-3b19-4399-828c-9ab025982112

> FDA 483 for Sky Medical Supplies and Equipments, LLC on September 17, 2021. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sky Medical Supplies and Equipments, LLC
- Inspection Date: 2021-09-17
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Sky Medical Supplies and Equipments, LLC in Parkland, FL, an initial importer, revealed six significant observations. The firm failed to establish fundamental quality system procedures, including those for corrective and preventive actions, medical device reporting, complaint handling, device distribution, storage area control, and document control. These deficiencies indicate a severe lack of basic operational controls.

## Related Officers

- [investigator](https://www.keypedia.com/people/aigbokhai-a-dirisu/a3dcb5ac-9940-4443-99f2-82537d6e177b)
- [Melanie W. Pishnery](https://www.keypedia.com/people/melanie-w-pishnery/ff4846b0-ffe1-4df0-9116-4bb238866b3a)

Company: https://www.keypedia.com/companies/sky-medical-supplies-and-equipments-llc/83ee88a1-a972-44e5-9765-6550c0b21400

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6