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

Form 483 issued March 19, 2024 · Ravensburg, Germany

Inspection: Mar 11 – Mar 19, 2024
Investigators: Bo Chi· Leiyun Boone· Olumide Martins
Observations: 4
Pages: 3
FEI number: 3005987757

In short: On March 19, 2024, FDA issued a Form 483 with 4 observations to Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) in Ravensburg, Baden-Wuerttemberg (FEI 3005987757) after an inspection that ran Mar 11 – Mar 19, 2024. The investigators were Bo Chi, Leiyun Boone and Olumide Martins. Most observations concern production and biologics CGMP.

At a glance

3 of 4 observations on this 483 concern production.

Production3

Biologics CGMP1

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 product purporting to be sterile are…
02
21 CFR 610.14
A procedure has not been stablished for performing identity testing on…
03
21 CFR 211.110 21 CFR 211.25
The visual inspection program…
04
21 CFR 211.186
Written procedures for IPS arug product manufacturing…

The full 483

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This inspection in context

The investigator

Bo Chi

8 documents · 2013–2024

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

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 211.113

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 4 observations on this Form 483, mostly about production and biologics CGMP. The opening words of each observation are shown on this page.

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

Bo Chi, Leiyun Boone and Olumide Martins are named on this Form 483, for the inspection of Mar 11 – Mar 19, 2024. 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 Mar 11 – Mar 19, 2024, and the Form 483 is dated March 19, 2024.

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.