Vetter Pharma Fertigung GmbH & Co. KG
Form 483 issued April 26, 2016 · Langenargen, Germany
- Inspection
- Apr 26, 2016
- Investigator
- Sharon K. Thoma
- Observations
- 6
- Pages
- 7
- FEI number
- 3002808846
In short: On April 26, 2016, FDA issued a Form 483 with 6 observations to Vetter Pharma Fertigung GmbH & Co. KG in Langenargen, Baden-Wuerttemberg (FEI 3002808846) after an inspection that ran Apr 26, 2016. The investigator was Sharon K. Thoma. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Quality system and production account for 5 of 6 observations.
Most cited: 21 CFR 211.100(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Deviations from written production and process control…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Written production and process control procedures are not followed in the execution of production and process…
This inspection in context
Sharon K. Thoma
9 documents · 2009–2016
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Pennsylvania.
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 211.100(b)
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 6 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Vetter Pharma Fertigung GmbH & Co. KG?
Sharon K. Thoma is named on this Form 483, for the inspection of Apr 26, 2016. Each investigator has a profile showing what they cite most.
When was Vetter Pharma Fertigung GmbH & Co. KG inspected by FDA?
The inspection ran Apr 26, 2016, and the Form 483 is dated April 26, 2016.
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.