Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse)

Form 483 issued August 19, 2022 · Ravensburg, Germany

Inspection: Aug 15 – Aug 19, 2022
Investigator: Wayne Seifert
Observations: 2
Pages: 2
FEI number: 3002270322

In short: On August 19, 2022, FDA issued a Form 483 with 2 observations to Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) in Ravensburg, Baden-Wuerttemberg (FEI 3002270322) after an inspection that ran Aug 15 – Aug 19, 2022. The investigator was Wayne Seifert. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).

At a glance

Facilities & equipment and production account for 2 of 2 observations.

Facilities & equipment1

Production1

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

01
21 CFR 211.67
Equipment and facilities in support of drug product manufacture…
02
21 CFR 211.100 21 CFR 211.113
Written procedures for production and process control designed to assure that the drug products have the…

The full 483

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This inspection in context

The investigator

Wayne Seifert

37 documents · 2010–2025

Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Germany.

The firm

Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) history

All 5 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.67

See how FDA wrote the same problem up elsewhere.

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Questions about this 483

What did FDA find at Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse)?

FDA listed 2 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.

Who inspected Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse)?

Wayne Seifert is named on this Form 483, for the inspection of Aug 15 – Aug 19, 2022. Each investigator has a profile showing what they cite most.

When was Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) inspected by FDA?

The inspection ran Aug 15 – Aug 19, 2022, and the Form 483 is dated August 19, 2022.

How do I get the full Form 483 for Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse)?

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.