483
Mercury Enterprises, Inc. dba Mercury MedicalMercury Enterprises, Inc. dba Mercury Medical – FDA 483, Dec 11, 2025
Record Details
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.
- Inspection date
- December 11, 2025
- Product type
- device
- Office
- Florida District Office
- Person
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ID · 834053f5-02c5-401d-83c4-49c38577ca47
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