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

Form 483 issued August 26, 2022 · Ravensburg, Germany

Inspection: Aug 22 – Aug 26, 2022
Investigators: Wayne Seifert· Zonglin Hu
Observations: 3
Pages: 2
FEI number: 3005987757

In short: On August 26, 2022, FDA issued a Form 483 with 3 observations to Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) in Ravensburg, Germany (FEI 3005987757) after an inspection that ran Aug 22 – Aug 26, 2022. The investigators were Wayne Seifert and Zonglin Hu. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).

At a glance

Production and facilities & equipment account for 2 of 3 observations.

Production1

Facilities & equipment1

Other1

Most cited: 21 CFR 211.100 (1×) · 211.67 (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 211.100
Written procedures for production and process control designed to assure that the drug products have the…
02
21 CFR 211.67
An equipment system in support of drug product manufacture…
03
A standard operating procedure in support of drug product…

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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 Mooswiesen) 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 211.100

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 Mooswiesen)?

FDA listed 3 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.

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

Wayne Seifert and Zonglin Hu are named on this Form 483, for the inspection of Aug 22 – Aug 26, 2022. Each investigator has a profile showing what they cite most.

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

The inspection ran Aug 22 – Aug 26, 2022, and the Form 483 is dated August 26, 2022.

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

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.