Octapharma AB
Form 483 issued October 3, 2016 · Stockholm, Sweden
- Investigators
- Cynthia Jim· Debra M. Emerson· I. Eee Cynthia Dim
- Observations
- 1
- Pages
- 17
- FEI number
- 3005559915
In short: On October 3, 2016, FDA issued a Form 483 with 1 observation to Octapharma AB in Stockholm, Sweden (FEI 3005559915). The investigators were Cynthia Jim, Debra M. Emerson, I. Eee Cynthia Dim and Mikhail Ovanesov.
What FDA observed
Preview: the opening words of each observation- 01
Pursuant to Section 704(b) of the Federal Food. Drug and i…
This inspection in context
Cynthia Jim
20 documents · 2012–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in North Carolina.
The firmOctapharma AB history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at Octapharma AB?
FDA listed 1 observation on this Form 483. The opening words of each observation are shown on this page.
Who inspected Octapharma AB?
Cynthia Jim, Debra M. Emerson, I. Eee Cynthia Dim and Mikhail Ovanesov are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Octapharma AB inspected by FDA?
This Form 483 is dated October 3, 2016.
How do I get the full Form 483 for Octapharma 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.