Rottendorf Pharma GmbH
Form 483 issued February 21, 2019 · Ennigerloh, Germany
- Inspection
- Feb 18 – Feb 21, 2019
- Investigator
- Patric C. Klotzbuecher
- Observations
- 1
- Pages
- 1
- FEI number
- 3003732290
In short: On February 21, 2019, FDA issued a Form 483 with 1 observation to Rottendorf Pharma GmbH in Ennigerloh, Germany (FEI 3003732290) after an inspection that ran Feb 18 – Feb 21, 2019. The investigator was Patric C. Klotzbuecher. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×) · 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…
This inspection in context
Patric C. Klotzbuecher
13 documents · 2014–2019
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmRottendorf Pharma GmbH history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Rottendorf Pharma GmbH?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Rottendorf Pharma GmbH?
Patric C. Klotzbuecher is named on this Form 483, for the inspection of Feb 18 – Feb 21, 2019. Each investigator has a profile showing what they cite most.
When was Rottendorf Pharma GmbH inspected by FDA?
The inspection ran Feb 18 – Feb 21, 2019, and the Form 483 is dated February 21, 2019.
How do I get the full Form 483 for Rottendorf Pharma GmbH?
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.