HP Halden Pharma AS
Form 483 issued September 3, 2019 · Halden, Norway
- Inspection
- Aug 26 – Sep 3, 2019
- Investigator
- Stephen D. Brown
- Observations
- 3
- Pages
- 3
- FEI number
- 3002608066
In short: On September 3, 2019, FDA issued a Form 483 with 3 observations to HP Halden Pharma AS in Halden, OSTFOLD (FEI 3002608066) after an inspection that ran Aug 26 – Sep 3, 2019. The investigator was Stephen D. Brown. Most observations concern quality system.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
An ield Alert Report was not submitted within three working days of receipt of information concerning…
- 02
Observation 2: scanned text, readable in the full document.
- 03
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Stephen D. Brown
42 documents · 2006–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmHP Halden Pharma AS history
The site's inspection history, in date order.
Similar 483sOther sites cited under 314.81(b)(1)(ii)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at HP Halden Pharma AS?
FDA listed 3 observations on this Form 483, mostly about quality system. The opening words of each observation are shown on this page.
Who inspected HP Halden Pharma AS?
Stephen D. Brown is named on this Form 483, for the inspection of Aug 26 – Sep 3, 2019. Each investigator has a profile showing what they cite most.
When was HP Halden Pharma AS inspected by FDA?
The inspection ran Aug 26 – Sep 3, 2019, and the Form 483 is dated September 3, 2019.
How do I get the full Form 483 for HP Halden Pharma AS?
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.