Siegfried Pharma AG Untere Bruhlstrasse 4
Form 483 issued December 13, 2019 · Zofingen, Switzerland
- Inspection
- Dec 9 – Dec 13, 2019
- Investigator
- Saleem A. Akhtar
- Observations
- 2
- Pages
- 4
- FEI number
- 3007045622
In short: On December 13, 2019, FDA issued a Form 483 with 2 observations to Siegfried Pharma AG Untere Bruhlstrasse 4 in Zofingen, Switzerland (FEI 3007045622) after an inspection that ran Dec 9 – Dec 13, 2019. The investigator was Saleem A. Akhtar. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
2 of 2 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165(a) (1×) · 211.160(b)(3) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Determinations of conformance to appropriate written specifications for acceptance are…
This inspection in context
Saleem A. Akhtar
35 documents · 2004–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmSiegfried Pharma AG Untere Bruhlstrasse 4 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Siegfried Pharma AG Untere Bruhlstrasse 4?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Siegfried Pharma AG Untere Bruhlstrasse 4?
Saleem A. Akhtar is named on this Form 483, for the inspection of Dec 9 – Dec 13, 2019. Each investigator has a profile showing what they cite most.
When was Siegfried Pharma AG Untere Bruhlstrasse 4 inspected by FDA?
The inspection ran Dec 9 – Dec 13, 2019, and the Form 483 is dated December 13, 2019.
How do I get the full Form 483 for Siegfried Pharma AG Untere Bruhlstrasse 4?
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