Siegfried PharmaChemikalien Minden Gmbh
Form 483 issued March 8, 2019 · Minden, Germany
- Inspection
- Mar 4 – Mar 8, 2019
- Investigator
- Alan P. Kurtzberg
- Observations
- 1
- Pages
- 1
- FEI number
- 3002807400
In short: On March 8, 2019, FDA issued a Form 483 with 1 observation to Siegfried PharmaChemikalien Minden Gmbh in Minden, Germany (FEI 3002807400) after an inspection that ran Mar 4 – Mar 8, 2019. The investigator was Alan P. Kurtzberg. Most observations concern production; the most-cited regulation is 21 CFR 211.105 (equipment identification).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.105 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
This inspection in context
Alan P. Kurtzberg
24 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmSiegfried PharmaChemikalien Minden Gmbh history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.105
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Siegfried PharmaChemikalien Minden Gmbh?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.105 (equipment identification). The opening words of each observation are shown on this page.
Who inspected Siegfried PharmaChemikalien Minden Gmbh?
Alan P. Kurtzberg is named on this Form 483, for the inspection of Mar 4 – Mar 8, 2019. Each investigator has a profile showing what they cite most.
When was Siegfried PharmaChemikalien Minden Gmbh inspected by FDA?
The inspection ran Mar 4 – Mar 8, 2019, and the Form 483 is dated March 8, 2019.
How do I get the full Form 483 for Siegfried PharmaChemikalien Minden Gmbh?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.