# Cosmed Group, Inc.   dba Cosmed of PA. – FDA 483, Mar 11, 2026

Source: https://www.keypedia.com/records/483/cosmed-group-inc-dba-cosmed-of-pa/1a5cab0e-db17-4a82-84b4-e5f21462f6b8

> FDA 483 for Cosmed Group, Inc.   dba Cosmed of PA. on March 11, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cosmed Group, Inc.   dba Cosmed of PA.
- Inspection Date: 2026-03-11
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Lynx Medical Pennsylvania, a contract medical device sterilizer in Erie, PA, revealed significant deficiencies in their risk management processes. The firm's FMEA Risk Analysis procedures were found inadequate, with unclear severity and detection rankings not consistently related to patient harm. This indicates a critical quality system issue regarding the safety and efficacy of their medical device sterilization processes.

## Related Officers

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

Company: https://www.keypedia.com/companies/cosmed-group-inc-dba-cosmed-of-pa/0c5ceffd-32f1-4ccd-9782-72db8f1ea7a5

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8