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Octapharma Plasma, Inc. Portsmouth FDA Inspection Record

FEI 3007166600 · Inspections, Form 483s, warning letters and import refusals

Octapharma Plasma, Inc. Portsmouth is an FDA-inspected facility (FEI 3007166600) located in Portsmouth, VA, US. RegDataLab tracks 5 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 30, 2021: No Action Indicated (NAI)
Inspections on record
5 (3 VAI, 2 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
1, latest Apr 22, 2019

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Mar 30, 2021No Action Indicated (NAI)No citations listed
Sep 26, 2018Voluntary Action Indicated (VAI)Adverse Reaction- Reports of Investigations (21 CFR 606.170(a))
Oct 28, 2016Voluntary Action Indicated (VAI)Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))
Jun 20, 2013No Action Indicated (NAI)No citations listed
Jun 28, 2011Voluntary Action Indicated (VAI)Accurate, indelible, legible (21 CFR 1271.270(a))

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Apr 22, 2019Class IIB-0012-2020Source Plasma
Blood product, collected in a manner that may have compromised product potency, was distributed.

FDA record score

3 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

4 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAISep 26, 20186 x 0.251.5
Class II recall B-0012-2020, this FEI as the recalling firmApr 22, 20194 x 0.251
Inspection classified VAIOct 28, 201610 years or older, so it adds no points0
Inspection classified VAIJun 28, 201110 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Octapharma Plasma, Inc. Portsmouth
Location
Portsmouth, VA (US)
Source
inspections

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.