Ophtapharm AG
Form 483 issued February 28, 2020 · Hettlingen, Switzerland
- Inspection
- Feb 20 – Feb 28, 2020
- Investigator
- Russell J. Glapion
- Observations
- 3
- Pages
- 2
- FEI number
- 3005531475
In short: On February 28, 2020, FDA issued a Form 483 with 3 observations to Ophtapharm AG in Hettlingen, Switzerland (FEI 3005531475) after an inspection that ran Feb 20 – Feb 28, 2020. The investigator was Russell J. Glapion. Most observations concern production and quality system.
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observation- 01
Individuals responsible for supervising the manufacture of a drug product lack the training to perform their…
- 02
Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and…
- 03
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate…
This inspection in context
Russell J. Glapion
18 documents · 2013–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New Jersey.
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 211.25(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ophtapharm AG?
FDA listed 3 observations on this Form 483, mostly about production and quality system. The opening words of each observation are shown on this page.
Who inspected Ophtapharm AG?
Russell J. Glapion is named on this Form 483, for the inspection of Feb 20 – Feb 28, 2020. Each investigator has a profile showing what they cite most.
When was Ophtapharm AG inspected by FDA?
The inspection ran Feb 20 – Feb 28, 2020, and the Form 483 is dated February 28, 2020.
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.