Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse)
Form 483 issued May 17, 2019 · Ravensburg, Germany
- Inspection
- May 13 – May 17, 2019
- Investigator
- Averse Prabhu P. Raju
- Observations
- 1
- Pages
- 3
- FEI number
- 3002270322
In short: On May 17, 2019, FDA issued a Form 483 with 1 observation to Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) in Ravensburg, Baden-Wuerttemberg (FEI 3002270322) after an inspection that ran May 13 – May 17, 2019. The investigator was Averse Prabhu P. Raju. Most observations concern production; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.188 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The following batch production and control records did not include complete information relating to the production…
This inspection in context
Averse Prabhu P. Raju
1 document · 2019
Cites 211.188 (batch production and control records) more than any other section. Most of their documents are for sites in Germany.
The firmVetter 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 483sOther sites cited under 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse)?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse)?
Averse Prabhu P. Raju is named on this Form 483, for the inspection of May 13 – May 17, 2019. 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 May 13 – May 17, 2019, and the Form 483 is dated May 17, 2019.
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.