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

Form 483 issued April 1, 2010 · Ravensburg, Germany

Inspection: Mar 22 – Apr 1, 2010
Investigator: Omotunde O. Osunsanmi
Observations: 9
Pages: 3
FEI number: 3002270322

In short: On April 1, 2010, FDA issued a Form 483 with 9 observations to Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) in Ravensburg, Baden-Wuerttemberg (FEI 3002270322) after an inspection that ran Mar 22 – Apr 1, 2010. The investigator was Omotunde O. Osunsanmi. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.198 (complaint files).

At a glance

Quality system and production account for 7 of 9 observations.

Quality system4

Production3

Laboratory controls2

Most cited: 21 CFR 211.198 (2×) · 211.160 (2×)

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 211.110 21 CFR 211.84
Visual inspection and sampling of incoming (b)(4) syringes (b)(4) washing, (b)(4) and syringe filling in-process controls…
02
21 CFR 211.198
Investigations, corrective and preventive actions into several confirmed complaints of (b)(4) Syringe Auto- injectors' partial/blockage of…
03
21 CFR 211.198
Investigation, corrective and preventive actions into (b)(4) complaints of defective safety device pre-activated ((b)(4) activated and…
04
21 CFR 211.22
There is no Quality Unit oversight of the aseptic media…

5 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The investigator

Omotunde O. Osunsanmi

13 documents · 2003–2020

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

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 211.198

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 9 observations on this Form 483, mostly about quality system, production and laboratory controls. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.

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

Omotunde O. Osunsanmi is named on this Form 483, for the inspection of Mar 22 – Apr 1, 2010. 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 Mar 22 – Apr 1, 2010, and the Form 483 is dated April 1, 2010.

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.