Ophtapharm AG
FDA inspection history in Hettlingen, Switzerland, 2017 to 2020
- 2
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Hettlingen, Switzerland.
- 2020One Form 483, at Hettlingen, Switzerland.
- 2020The longest 483 on file: 3 observations over 2 pages at Hettlingen, Switzerland.
Cited most
Across all Ophtapharm AG observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.103Calculation of yield1
- 21 CFR 211.165(e)Testing and release for distribution1
- 21 CFR 211.25(b)Personnel qualifications1
The complete Ophtapharm AG file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Hettlingen, Switzerland
Two Form 483s · 2017 to 2020 · 5 observations
Latest: Form 483, Feb 28, 2020 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-02-28 | 483 Form 483 | Hettlingen, Switzerland | 3 | $99 |
| 2017-12-12 | 483 Form 483 | Hettlingen, Switzerland | 2 | $99 |
Investigators on these documents
FEI number 3005531475 · most recent document Feb 28, 2020
About Ophtapharm AG
How many FDA Form 483s has Ophtapharm AG received?
FDA Intel has 2 Form 483s on file for Ophtapharm AG; the most recent is dated Feb 28, 2020.
When was Ophtapharm AG last inspected by FDA?
The most recent FDA inspection document on file for Ophtapharm AG is a Form 483 dated Feb 28, 2020, for the site in Hettlingen, Switzerland.
What did FDA cite at Ophtapharm AG?
The regulations cited most in the observations on file for Ophtapharm AG are 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.103 (Calculation of yield), 1 time; 21 CFR 211.165(e) (Testing and release for distribution), 1 time.