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

Form 483 issued November 2, 2017 · Ravensburg, Germany

Inspection: Oct 23 – Nov 2, 2017
Investigators: Mihaly S. Ligmond· Simone E. Pitts
Observations: 4
Pages: 4
FEI number: 3005987757

In short: On November 2, 2017, 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 Oct 23 – Nov 2, 2017. The investigators were Mihaly S. Ligmond and Simone E. Pitts. Most observations concern production and quality system.

At a glance

Observations span 4 systems, led by production.

Production1

Quality system1

Materials1

Packaging & labeling1

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 microbial contamination of drug products purporting to…
02
21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
03
21 CFR 211.84
Each lot of components is not withheld from use until the lot has been sampled, tested…
04
21 CFR 211.122
Access to the storage area for labels and labeling materials is not…

The full 483

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This inspection in context

The investigator

Mihaly S. Ligmond

20 documents · 2006–2024

Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ireland.

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, quality system and materials. The opening words of each observation are shown on this page.

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

Mihaly S. Ligmond and Simone E. Pitts are named on this Form 483, for the inspection of Oct 23 – Nov 2, 2017. 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 Oct 23 – Nov 2, 2017, and the Form 483 is dated November 2, 2017.

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.