CSL Plasma Inc. — FDA Facility Profile

FEI 3014286251

CSL Plasma Inc. is an FDA-inspected facility (FEI 3014286251) located in Charlotte, NC, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
May 25, 2023: No Action Indicated (NAI)
Inspections on record
1 (1 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 Apr 2, 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
May 25, 2023No 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
Apr 2, 2020Not yet classifiedB-0518-2020Source Plasma
Source Plasma, collected from a donor who was illiterate, were distributed.
Mar 2, 2020Not yet classifiedB-0495-2020Source Plasma
Source Plasma, collected from a donor who received a tattoo within 12 months of donation, were distributed.

Facility details

Company
CSL Plasma Inc.
Location
Charlotte, NC (US)
Source
inspections

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