Atlas

FDA-Inspected Site

Teka Portugal S.A.

3 FDA inspections are on record for Teka Portugal S.A. in Ilhavo, Portugal.

483· Form 483 issued

Ilhavo, Portugal · Last updated July 10, 2026

Overview

  • 3 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2022-11-11.

At a glance

Inspections

3

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
10 Nov 2022 – 11 Nov 2022Medical Devices & Rad Health483View 483 →
27 Apr 2018Medical Devices & Rad Health483View 483 →
5 May 2016 – 6 May 2016Medical Devices & Rad Health483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

11 Nov 2022
21 CFR 1010.2(c)

Certification not based on adequate test/testing program

Cited by Gregory M Bessette, Francis Pham

11 Nov 2022
21 CFR 1030.10(c)(3)(i)

tests--errors and uncertainties accounted for

Cited by Gregory M Bessette, Francis Pham

27 Apr 2018
21 CFR 1030.10(c)(2)(vi)

Means to monitor interlocks

Cited by Gregory M Bessette, Michael P Sweeney

27 Apr 2018
21 CFR 1030.10(c)(3)(i)

tests--errors and uncertainties accounted for

Cited by Gregory M Bessette, Michael P Sweeney

6 May 2016
21 CFR 1030.10(c)(3)(i)

tests--errors and uncertainties accounted for

Cited by Michael P Sweeney, Joseph C Teixeira

Investigators

FDA investigators tied to this site in the record.

Gregory M Bessette2 insp.
Michael P Sweeney2 insp.
Francis Pham1 insp.
Joseph C Teixeira1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 1030.10(c)(3)(i)Cited across public-safe Form 483 observations3x
21 CFR 1010.2(c)Cited across public-safe Form 483 observations1x
21 CFR 1030.10(c)(2)(vi)Cited across public-safe Form 483 observations1x
21 CFR 1030.10(c)(3)(iii)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Teka Portugal S.A.'s 3 Form 483s

Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat