# FDA EIR - Specialty Appliances LLC - February 24, 2022

Source: https://www.keypedia.com/records/eir/specialty-appliances-llc/0b71baae-5d2f-49b1-b08e-175133ec4bca

> FDA EIR for Specialty Appliances LLC on February 24, 2022. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Specialty Appliances LLC
- Inspection Date: 2022-02-24
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: Specialty Appliances LLC underwent a preannounced QSIT Level I (Abbreviated) FDA inspection from February 22-24, 2022. The inspection, conducted under Compliance Program 7382.845 for medical device manufacturers, focused on the company's operations as a Specification Developer, Manufacturer, and Repackager/Relabeler of Class I and Class II custom dental appliances. The regulatory review primarily covered the Corrective and Preventive Action (CAPA) and Production and Process Controls (P&PC) subsystems. This included an examination of procedures related to quality policy, management review, risk management, calibration, nonconformance, personnel training, and medical device reporting. Additionally, the firm's CAPA log, nonconformance log, preventive maintenance schedule, and calibration log were reviewed. Notably, the inspection concluded without any significant deficiencies of the Quality System Regulations being observed. Consequently, no Form FDA 483, Inspectional Observations, was issued, indicating compliance with regulatory requirements. No samples were collected, and no refusals were encountered during the inspection, requiring no specific actions from the company.

## Related Documents

- [EIR - 2016-09-09](https://www.keypedia.com/records/eir/specialty-appliances-llc/e3303978-0f56-4685-b43b-bf3251dc8225)
- [EIR - 2022-02-24](https://www.keypedia.com/records/eir/specialty-appliances-llc/45946e56-b65d-4196-b62d-730c9dae2c5a)

## Related Officers

- [recipient](https://www.keypedia.com/people/scott-a-huge/01ee6919-b73f-4bef-a52a-3adbe69a6301)
- [company_representative](https://www.keypedia.com/people/timothy-s-jackson/169f82a9-8dd3-496b-8a2f-c30ab949a918)
- [company_representative](https://www.keypedia.com/people/john-s-jordan/3086a300-87e8-4c3b-8cda-0f1719aeddc9)
- [company_representative](https://www.keypedia.com/people/joanie-r-elrod/434965b7-922f-44c0-897b-815b3b029c4b)
- [company_representative](https://www.keypedia.com/people/carolyn-e-thomas/74af5fb3-ba93-483c-ba33-c094d9262d97)

Company: https://www.keypedia.com/companies/specialty-appliances-llc/5578dafc-5079-485b-9b0f-134650e1a6a0

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7