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.
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
Inspected site
TPTeka Portugal S.A.Ilhavo, Portugal
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1030.10(c)(2)(vi) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1030.10(c)(3)(i) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 2 observations
Every observation in full, 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