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•United States

Trinity Sterile, Inc., Salisbury, MD – FDA Inspections

Inspection records and compliance data for Trinity Sterile, Inc. in Salisbury, Maryland. 5 FDA inspections on record, 2 Form 483s, last inspected May 23, 2024.

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Company Profile

This profile covers Trinity Sterile, Inc. based in Salisbury, Maryland, United States.

FDA Inspection History

FDA inspections
5
OAI
0
VAI
2
NAI
3
Form 483s
2
Warning letters
0

First inspected September 1, 2010. Last inspected May 23, 2024.

Most cited issue areas

  • Lack of or inadequate procedures2 inspections
  • Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
  • Design control - no procedures1 inspection

FDA inspections (5)

DateResultFDA center(s)Insp. #
May 23, 2024NAIMedical Devices & Rad Health · Compliance: Devices1239929
April 26, 2019VAIMedical Devices & Rad Health · Compliance: Devices1087531
March 13, 2017VAIMedical Devices & Rad Health · Compliance: Devices1004661
February 13, 2013NAIMedical Devices & Rad Health · Postmarket Assurance: Devices818470
September 1, 2010NAIMedical Devices & Rad Health · Postmarket Assurance: Devices678565
FDA documents

No Form 483s, Warning Letters or EIRs on record.

Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

Robert H. Christenson, Ph.D.
Alphatec Spine, Inc.
Dexall Biomedical Labs, Inc.
Vapotherm, Inc.
ELEKTA INC.
James Gammie, MD
Paul Demarco, MD
Senseonics, Inc.
Thomas E. Clinch, MD
John C. Wang, MD
Company Information

Name

Trinity Sterile, Inc.

FEI Number

1000123297

Address

201 Kiley Dr, Salisbury, Maryland 21801, United States

Country

United States

ID: 3f7ce0d7-636b-463b-ad3f-bdbac7edeb4c

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