# FDA 483 - Applied Medical Coatings, LLC - October 13, 2021

Source: https://www.globalkeysolutions.net/records/483/applied-medical-coatings-llc/31e237da-4fab-4857-a80b-ec3eb5655ecc

> FDA 483 for Applied Medical Coatings, LLC on October 13, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Applied Medical Coatings, LLC
- Inspection Date: 2021-10-13
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Applied Medical Coatings, LLC, a medical device contract manufacturer in Lockport, NY, was cited for six observations during an FDA inspection. The inspection revealed significant deficiencies in process validation, process controls, corrective and preventive actions, control of nonconforming product, calibration procedures, and personnel training documentation. These issues indicate a lack of adequate quality system procedures and adherence to established requirements.

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- [483 - 2025-06-27](https://www.globalkeysolutions.net/records/483/applied-medical-coatings-llc/666196c7-88a7-4356-bf7f-36bff8c5622d)

## Related Officers

- [Matthew D. Schnittker](https://www.globalkeysolutions.net/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.globalkeysolutions.net/companies/applied-medical-coatings-llc/fd5cbabc-79d7-4585-90a5-9074cf3dad4f

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