Ophtapharm AG
Form 483 issued December 12, 2017 · Hettlingen, Switzerland
- Inspection
- Dec 4 – Dec 12, 2017
- Investigator
- Yasamin Ameri
- Observations
- 2
- Pages
- 3
- FEI number
- 3005531475
In short: On December 12, 2017, FDA issued a Form 483 with 2 observations to Ophtapharm AG in Hettlingen, Switzerland (FEI 3005531475) after an inspection that ran Dec 4 – Dec 12, 2017. The investigator was Yasamin Ameri. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165(e) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The accuracy, sensitivity and reproducibility of test methods have not…
This inspection in context
Yasamin Ameri
20 documents · 2015–2022
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in India.
The firmOphtapharm AG history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ophtapharm AG?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Ophtapharm AG?
Yasamin Ameri is named on this Form 483, for the inspection of Dec 4 – Dec 12, 2017. Each investigator has a profile showing what they cite most.
When was Ophtapharm AG inspected by FDA?
The inspection ran Dec 4 – Dec 12, 2017, and the Form 483 is dated December 12, 2017.
How do I get the full Form 483 for Ophtapharm AG?
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.