BPC Plasma, Inc. — FDA Facility Profile

FEI 1072431

BPC Plasma, Inc. is an FDA-inspected facility (FEI 1072431) located in Fort Myers, FL, US. RegDataLab tracks 6 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Aug 4, 2023: No Action Indicated (NAI)
Inspections on record
6 (6 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
2, latest Jul 3, 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
Aug 4, 2023No Action Indicated (NAI)No citations listed
Sep 23, 2021No Action Indicated (NAI)No citations listed
Feb 2, 2015No Action Indicated (NAI)No citations listed
Nov 20, 2012No Action Indicated (NAI)No citations listed
Jul 21, 2011No Action Indicated (NAI)No citations listed
Feb 11, 2009No 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 3, 2020Not yet classifiedB-0603-2020Source Plasma
Source Plasma, for which donor eligibility was incomplete, was distributed.
Dec 15, 2015Not yet classifiedB-0374-16Source Plasma
Source plasma product, in quarantine pending post donation investigation regarding prior incarceration, was distributed.

Facility details

Company
BPC Plasma, Inc.
Location
Fort Myers, FL (US)
Source
inspections

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