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Community Blood Center FDA Inspection Record

FEI 1000523928 · Inspections, Form 483s, warning letters and import refusals

Community Blood Center is an FDA-inspected facility (FEI 1000523928) located in Portland, OR, US. RegDataLab tracks 6 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Sep 19, 2019: No Action Indicated (NAI)
Inspections on record
6 (2 VAI, 4 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 Sep 3, 2005

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
Sep 19, 2019No Action Indicated (NAI)No citations listed
Sep 21, 2016No Action Indicated (NAI)No citations listed
May 6, 2015No Action Indicated (NAI)No citations listed
Jun 12, 2013No Action Indicated (NAI)No citations listed
May 5, 2011Voluntary Action Indicated (VAI)Eligibility statement--basis of determination (21 CFR 1271.55(a)(2))
Feb 5, 2010Voluntary Action Indicated (VAI)Records stating determination not completed (21 CFR 1271.60(c)(2))
All core requirements covered in program (21 CFR 1271.160(a))
Actions verified, short and long term solutions (21 CFR 1271.160(b)(3))
Deviations--evaluation, cause, corrective action (21 CFR 1271.160(b)(6))
and 1 more

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
Sep 3, 2005Class IIB-0610-6Achilles Tendon with Bone, Frozen, Irradiated Tissue
Human tissue, positive for Propionibacterium acnes on final culture after processing, was distributed.

Facility details

Company
Community Blood Center
Location
Portland, OR (US)
Source
inspections

FDA data resources

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