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BPC Plasma, Inc. — FDA Facility Profile

FEI 1172435

BPC Plasma, Inc. is an FDA-inspected facility (FEI 1172435) located in Augusta, GA, US. RegDataLab tracks 4 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Mar 14, 2019: No Action Indicated (NAI)
Inspections on record
4 (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
4, latest Jul 16, 2020

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 14, 2019No Action Indicated (NAI)No citations listed
Jul 20, 2016No Action Indicated (NAI)No citations listed
Nov 13, 2015No Action Indicated (NAI)No citations listed
Oct 26, 2012No Action Indicated (NAI)No citations listed

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
Jul 16, 2020Class IIIB-0617-2020Source Plasma
Source Plasma, for which donor eligibility was incomplete, was distributed.
Jul 16, 2020Class IIIB-0635-2020Source Plasma
Source Plasma, for which donor eligibility screening was incomplete, were distributed.
Mar 13, 2013Class IIB-1809-13Source Plasma
Blood products, collected from a donor who did not have a complete physical examination, were distributed.
Jul 11, 2000Class IIB-1220-3Source Plasma
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors.

Facility details

Company
BPC Plasma, Inc.
Location
Augusta, GA (US)
Source
inspections

FDA data resources

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