Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)
Form 483 issued July 17, 2019 · Ravensburg, Germany
- Inspection
- Jul 11 – Jul 17, 2019
- Investigators
- Ashley Queen· Michael R. Shanks
- Observations
- 1
- Pages
- 1
- FEI number
- 3005987757
In short: On July 17, 2019, FDA issued a Form 483 with 1 observation to Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) in Ravensburg, Baden-Wuerttemberg (FEI 3005987757) after an inspection that ran Jul 11 – Jul 17, 2019. The investigators were Ashley Queen and Michael R. Shanks. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
SOP 10082, rev. 29, January 15, 2019, “Hygienic Behavior in Pharmaceutical Production,” is not always followed…
This inspection in context
Ashley Queen
2 documents · 2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Germany.
The firmVetter 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 483sOther sites cited under 211.113
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 Mooswiesen)?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)?
Ashley Queen and Michael R. Shanks are named on this Form 483, for the inspection of Jul 11 – Jul 17, 2019. 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 Jul 11 – Jul 17, 2019, and the Form 483 is dated July 17, 2019.
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.