# FDA EIR - Elite Medical Supply of New York, LLC - November 16, 2018

Source: https://www.keypedia.com/records/eir/elite-medical-supply-of-new-york-llc/55df72e5-becd-48e5-8498-8bca0acc7b58

> FDA EIR for Elite Medical Supply of New York, LLC on November 16, 2018. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Elite Medical Supply of New York, LLC
- Inspection Date: 2018-11-16
- Product Type: devices
- Office Name: New Orleans District Office
- Summary: An FDA Quality System Inspection Technique (QSIT) Level I inspection was conducted at Elite Medical Supply of New York, LLC's manufacturing facility in Hendersonville, TN, from November 14-16, 2018. The company manufactures Class II powered muscle stimulators/transcutaneous electrical nerve stimulators. The inspection, part of the FY19 Work Plan and aligned with Compliance Program 7382.845, identified three significant observations documented on an FDA Form 483.

The main issues included inadequately established procedures for acceptance activities, as a failed PCB subassembly was used in a final product without proper verification or disposal, violating 21 CFR 820.80(a). Furthermore, software validation for automated data processing systems, particularly for the Device Build Assembly Form's flagging function and the overall off-the-shelf software systems, was not adequately documented or performed, contravening 21 CFR 820.70(i). Lastly, document control procedures were not adequately established, with evidence of a controlled document being used in production before its official approval and release, in violation of 21 CFR 820.40.

Elite Medical Supply of New York, LLC management acknowledged the observations and "Promised to Correct" the deficiencies. The company was reminded of its ongoing responsibility to comply with the Food, Drug, and Cosmetic Act and the Quality System Regulation, and to implement necessary corrective actions to ensure proper quality system functionality.

## Related Documents

- [EIR - 2018-11-16](https://www.keypedia.com/records/eir/elite-medical-supply-of-new-york-llc/44f3bb92-3f3d-418e-a515-e0ae833e8f19)

## Related Officers

- [company_representative](https://www.keypedia.com/people/john-j-mcgrady/4ed891b8-9da9-41cc-b668-af909d85a8df)
- [Mary A. Millner](https://www.keypedia.com/people/mary-a-millner/bd8911cf-849d-41d2-ae12-dd4bad66e798)
- [company_representative](https://www.keypedia.com/people/scott-m-lupiani/e938844c-7d73-4ed8-8db6-932cc3630d6e)

Company: https://www.keypedia.com/companies/elite-medical-supply-of-new-york-llc/3621cbd4-85b1-47d4-a647-9f3cf38c9151

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea