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Cotton High Tech S.L.( d/ba COHITECH), Balsareny, Spain – FDA Inspections

Inspection records and compliance data for Cotton High Tech S.L.( d/ba COHITECH) in Balsareny. 3 FDA inspections on record (1 OAI), 1 Form 483, last inspected March 08, 2018.

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Company Profile

This profile covers Cotton High Tech S.L.( d/ba COHITECH) based in Balsareny, Spain.

FDA Inspection History

FDA inspections
3
OAI
1
VAI
1
NAI
0
Unclassified
1
Form 483s
1
Warning letters
0

First inspected August 8, 2013. Last inspected March 8, 2018.

Most cited issue areas

  • Buildings1 inspection
  • Design changes - Lack of or Inadequate Procedures1 inspection
  • DHR content1 inspection

FDA inspections (3)

DateResultFDA center(s)Insp. #
March 8, 2018Not classifiedMedical Devices & Rad Health · Compliance: Devices1044917
February 20, 2015VAIMedical Devices & Rad Health · Compliance: Devices917252
August 8, 2013OAIMedical Devices & Rad Health · Compliance: Devices852538
FDA documents

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

Related Companies (10)

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

AMO (Abbott Medical Optics) Spain
Transcendencias Comerciales S.L.
B.T.I. Biotechnology Institute, S.L.
OPERON, S.A.
Intermedic Arfran S.A.
B. Braun Surgical, S.A.
CAPENERGY MEDICAL, S.L.
Carrion, Susana Benlloch, Clinical Investigator
HERSILL, S.L.
OPTILASA, S.L.
Company Information

Name

Cotton High Tech S.L.( d/ba COHITECH)

FEI Number

3006517653

Address

Colonia La Rabeia S/N, Balsareny, Spain

Country

Spain

ID: 8f24972b-b198-464c-b176-782576b68257

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