Vetter Pharma Fertigung GmbH & Co. KG
Form 483 issued April 24, 2024 · Langenargen, Germany
- Investigator
- Bo Chi
- Observations
- 3
- Pages
- 3
- FEI number
- 3002808846
In short: On April 24, 2024, FDA issued a Form 483 with 3 observations to Vetter Pharma Fertigung GmbH & Co. KG in Langenargen, Baden-Wuerttemberg (FEI 3002808846). The investigator was Bo Chi. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×) · 211.110 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug product (DP) purporting to be sterile are…
- 02
The visual inspection program for ®® is deficient and was not able to remove defects, resulting…
- 03
Environmental monitoring of aseptic processing areas following critical Grade A…
This inspection in context
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 firmVetter Pharma Fertigung GmbH & Co. KG history
All 2 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?
FDA listed 3 observations 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?
Bo Chi is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Vetter Pharma Fertigung GmbH & Co. KG inspected by FDA?
This Form 483 is dated April 24, 2024.
How do I get the full Form 483 for Vetter Pharma Fertigung GmbH & Co. KG?
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.