# FDA 483 - LC Medical Concepts, Inc - February 25, 2020

Source: https://www.keypedia.com/records/483/lc-medical-concepts-inc/dc2047d2-0d5c-4ccd-906d-00a027f71859

> FDA 483 for LC Medical Concepts, Inc on February 25, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LC Medical Concepts, Inc
- Inspection Date: 2020-02-25
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Medical Concepts, Inc. in Rochester, NY, a medical device manufacturer, received a Form FDA 483 citing a repeat observation related to inadequate process validation. The firm failed to adequately validate the sterilization process for its UNI Negative Pressure Wound Therapy Kits. This included not performing required audits and failing to revalidate the process after a previous audit showed positive growth samples, indicating a significant potential risk to product sterility.

## Related Documents

- [WARNING_LETTER - 2018-10-23](https://www.keypedia.com/records/warning_letter/lc-medical-concepts-inc/37b54f34-3241-4262-9fb7-fc30a05c2d37)

## Related Officers

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

Company: https://www.keypedia.com/companies/lc-medical-concepts-inc/f76c0ac4-c554-4d77-9e48-5f1ef75468ef

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