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

Form 483 issued September 20, 2024 · Ravensburg, Germany

Observations: 2
Pages: 2
FEI number: 3002270322

In short: On September 20, 2024, FDA issued a Form 483 with 2 observations to Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) in Ravensburg, Baden-Wuerttemberg (FEI 3002270322). Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).

At a glance

Production and quality system account for 2 of 2 observations.

Production1

Quality system1

Most cited: 21 CFR 211.113 (1×) · 211.22 (1×)

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 211.113
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
02
21 CFR 211.22
Quality Assurance is…

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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.

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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 production and quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.

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

This Form 483 is dated September 20, 2024.

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

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