# FDA 483 - Mercury Enterprises, Inc. dba Mercury Medical - December 11, 2025

Source: https://www.globalkeysolutions.net/records/483/mercury-enterprises-inc-dba-mercury-medical/834053f5-02c5-401d-83c4-49c38577ca47

> FDA 483 for Mercury Enterprises, Inc. dba Mercury Medical on December 11, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mercury Enterprises, Inc. dba Mercury Medical
- Inspection Date: 2025-12-11
- Product Type: device
- Office Name: Florida District Office
- Summary: An FDA inspection of Mercury Enterprises, Inc. dba Mercury Medical, a medical device manufacturer in Clearwater, FL, revealed significant deficiencies in their quality system. The firm failed to adequately establish corrective and preventive action procedures and incoming product acceptance activities. These failures led to the distribution of defective Neo-Tee T-Piece Resuscitators, resulting in two Class I recalls.

## Related Officers

- [Chad E. Schmear](https://www.globalkeysolutions.net/people/chad-e-schmear/275a4c57-d288-46f9-8257-64fcd96159ce)

Company: https://www.globalkeysolutions.net/companies/mercury-enterprises-inc-dba-mercury-medical/597d6981-c5ca-43cc-8951-278ccf86de9b

Office: https://www.globalkeysolutions.net/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9