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Company
•United States•Public company, NASDAQ: TNDM

Tandem Diabetes Care, Inc. (NASDAQ: TNDM), San Diego, CA – FDA Inspections

Inspection records and compliance data for Tandem Diabetes Care, Inc. in San Diego, California. 5 FDA inspections on record, 2 Form 483s, last inspected March 23, 2023. Publicly traded as NASDAQ: TNDM.

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Company Profile

This profile covers Tandem Diabetes Care, Inc. based in San Diego, California, United States.

FDA Inspection History

FDA inspections
5
OAI
0
VAI
4
NAI
1
Form 483s
2
Warning letters
0

First inspected December 23, 2014. Last inspected March 23, 2023.

Most cited issue areas

  • Lack of or inadequate procedures2 inspections
  • Design Validation - Risk analysis not performed/inadequate1 inspection
  • Equipment design and installation1 inspection

FDA inspections (5)

DateResultFDA center(s)Insp. #
March 23, 2023VAIMedical Devices & Rad Health · Compliance: Devices1200609
October 15, 2021VAIMedical Devices & Rad Health · Postmarket Assurance: Devices1155101
June 19, 2018NAIMedical Devices & Rad Health · Bioresearch Monitoring1057284
November 18, 2016VAIMedical Devices & Rad Health · Compliance: Devices998792
December 23, 2014VAIMedical Devices & Rad Health · Compliance: Devices910518
FDA documents

Form 483s (3)

  • Form 483s · March 23, 2023
  • Form 483s · October 15, 2021
  • Form 483s · December 23, 2014

EIRs (1)

  • EIRs · November 18, 2016
People (3)
Scott K. Zika
Person
Donna L. Tartaglino Besone
Person
Janet Pulver
Person
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Company Information

Name

Tandem Diabetes Care, Inc.

Stock ticker

TNDM

Exchange

NASDAQ

Share price

$17.51

Market cap

$1.2B

Price as of

November 13, 2026

FEI Number

3007981285

Address

11075 Roselle St, San Diego, California 92121, United States

Country

United States

ID: 55c8bf38-f959-46dd-8954-5ac3480bea3e

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