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Heraeus Medical Components, Srl, Cartago, Costa Rica – FDA Inspections

Inspection records and compliance data for Heraeus Medical Components, Srl in Cartago. 1 FDA inspection on record, 1 Form 483, last inspected August 03, 2023.

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Company Profile

This profile covers Heraeus Medical Components, Srl based in Cartago, Costa Rica.

FDA Inspection History

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

Inspected August 3, 2023.

Most cited issue areas

  • Documentation1 inspection
  • Environmental control Lack of or inadequate procedures1 inspection
  • Lack of or inadequate process validation1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
August 3, 2023VAIMedical Devices & Rad Health · Compliance: Devices1214916
FDA documents

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

Related Companies (10)

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

SWAV CR SRL
Bayer Medical SRL
Nevro Medical SRL
SMC Costa Rica Division S.R.L.
Baxter Productos Medicos, Ltda.
Cardinal Health Costa Rica, S.A.
ICU Medical Costa Rica Ltd.
UTITEC MEDICAL S.A.
Cyberonics Latam SLR
ALLERGAN
Company Information

Name

Heraeus Medical Components, Srl

FEI Number

3013666336

Address

Building 29, Parque Industrial Zona Franca La Lima Guadalupe, Cartago, Costa Rica

Country

Costa Rica

ID: 8ee2c279-b891-4189-815b-00e8dce1f9f1

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