Sever Pharma Solutions AB
Form 483 issued December 15, 2017 · Malmo, Sweden
- Inspection
- Dec 11 – Dec 15, 2017
- Investigators
- Of Es James Norman· Ofthis James Norman
- Observations
- 4
- Pages
- 4
- FEI number
- 3004620701
In short: On December 15, 2017, FDA issued a Form 483 with 4 observations to Sever Pharma Solutions AB in Malmo, Sweden (FEI 3004620701) after an inspection that ran Dec 11 – Dec 15, 2017. The investigators were Of Es James Norman and Ofthis James Norman. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Control procedures are not established which monitor the output of those manufacturing processes that may be…
- 03
Electronic records are used, but they do not meet retention requirements to ensure that they are…
- 04
Equipment surfaces that contact in-process materials are reactive, additive, or absorptive so as to alter the…
This inspection in context
Of Es James Norman
1 document · 2017
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in Sweden.
The firmSever Pharma Solutions AB history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sever Pharma Solutions AB?
FDA listed 4 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Sever Pharma Solutions AB?
Of Es James Norman and Ofthis James Norman are named on this Form 483, for the inspection of Dec 11 – Dec 15, 2017. Each investigator has a profile showing what they cite most.
When was Sever Pharma Solutions AB inspected by FDA?
The inspection ran Dec 11 – Dec 15, 2017, and the Form 483 is dated December 15, 2017.
How do I get the full Form 483 for Sever Pharma Solutions AB?
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.