Atlas

Form 483

Teka Portugal S.A. Form 483, 2022-11-11

FDA issued a Form 483 to Teka Portugal S.A. on 2022-11-11 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Teka Portugal S.A. · Ilhavo, Portugal · Issued November 11, 2022

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

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

Inspected site

TPTeka Portugal S.A.Ilhavo, Portugal

Inspection team

GMGregory M Bessette
FPFrancis Pham

Cited regulations

CFR citations associated with this Form 483.

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

Full 483 report

Get the verbatim text of all 2 observations

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere