HP Halden Pharma AS
FDA inspection history in Halden, Norway, 2019
- 1
- Form 483
Every document, by year
- Form 483
2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Halden, Norway.
Cited most
Across all HP Halden Pharma AS observations on file
- 21 CFR 211.192Production record review1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 314.81(b)(1)(ii)Other postmarketing reports1
The complete HP Halden Pharma AS file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Halden, Norway
One Form 483 · 2019 · 3 observations
Latest: Form 483, Sep 3, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-09-03 | 483 Form 483 | Halden, Norway | 3 | $99 |
Investigators on these documents
FEI number 3002608066 · most recent document Sep 3, 2019
About HP Halden Pharma AS
How many FDA Form 483s has HP Halden Pharma AS received?
FDA Intel has 1 Form 483 on file for HP Halden Pharma AS; the most recent is dated Sep 3, 2019.
When was HP Halden Pharma AS last inspected by FDA?
The most recent FDA inspection document on file for HP Halden Pharma AS is a Form 483 dated Sep 3, 2019, for the site in Halden, Norway.
What did FDA cite at HP Halden Pharma AS?
The regulations cited most in the observations on file for HP Halden Pharma AS are 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.22(d) (Responsibilities of quality control unit), 1 time; 21 CFR 314.81(b)(1)(ii) (Other postmarketing reports), 1 time.