CSL Plasma Inc.

FDA Regulatory Profile

CSL Plasma Inc. has 0 FDA recalls, 683 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Oct 16, 2026 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections683Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 16, 2026Akron, OHBiologicsNo Action Indicated (NAI)1525348
Oct 8, 2026Cincinnati, OHBiologicsNo Action Indicated (NAI)3013704884
Oct 5, 2026Mckeesport, PABiologicsNo Action Indicated (NAI)3013771915
Oct 5, 2026Sterling Heights, MIBiologicsNo Action Indicated (NAI)3012981862
Sep 29, 2026Dover, DEBiologicsNo Action Indicated (NAI)3024593669
Jul 31, 2026Clifton, NJBiologicsNo Action Indicated (NAI)3015745056
Jul 17, 2026Waukegan, ILBiologicsNo Action Indicated (NAI)3023206119
Jun 26, 2026Gastonia, NCBiologicsNo Action Indicated (NAI)3015889890
Jun 18, 2026Schenectady, NYBiologicsNo Action Indicated (NAI)3015305663
May 21, 2026Shreveport, LABiologicsNo Action Indicated (NAI)3015186996
May 21, 2026O'Fallon, ILBiologicsNo Action Indicated (NAI)3014666873
May 7, 2026Las Vegas, NVBiologicsNo Action Indicated (NAI)3023086160
Apr 29, 2026Milwaukee, WIBiologicsVoluntary Action Indicated (VAI)3023209390
Apr 24, 2026Dallas, TXBiologicsNo Action Indicated (NAI)3010375375
Apr 16, 2026Orange City, FLBiologicsNo Action Indicated (NAI)3012194482
Apr 9, 2026Whitestown, INBiologicsVoluntary Action Indicated (VAI)3014026593
Mar 5, 2026Douglas, AZBiologicsNo Action Indicated (NAI)3013950154
Feb 25, 2026Jackson, MIBiologicsNo Action Indicated (NAI)3014947859
Feb 13, 2026Boise, IDBiologicsNo Action Indicated (NAI)3014576072
Feb 6, 2026Philadelphia, PABiologicsVoluntary Action Indicated (VAI)3022099864

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 1525348Akron, OH6Oct 16, 2026
FEI 3013704884Cincinnati, OH2Oct 8, 2026
FEI 3012981862Sterling Heights, MI2Oct 5, 2026
FEI 3013771915Mckeesport, PA2Oct 5, 2026
FEI 3024593669Dover, DE1Sep 29, 2026
FEI 3015745056Clifton, NJ1Jul 31, 2026
FEI 3023206119Waukegan, IL1Jul 17, 2026
FEI 3015889890Gastonia, NC1Jun 26, 2026
FEI 3015305663Schenectady, NY1Jun 18, 2026
FEI 3014666873O'Fallon, IL1May 21, 2026
FEI 3015186996Shreveport, LA1May 21, 2026
FEI 3023086160Las Vegas, NV1May 7, 2026
FEI 3023209390Milwaukee, WI1Apr 29, 2026
FEI 3010375375Dallas, TX2Apr 24, 2026
FEI 3012194482Orange City, FL2Apr 16, 2026
FEI 3014026593Whitestown, IN3Apr 9, 2026
FEI 3013950154Douglas, AZ1Mar 5, 2026
FEI 3014947859Jackson, MI1Feb 25, 2026
FEI 3014576072Boise, ID1Feb 13, 2026
FEI 3022099864Philadelphia, PA1Feb 6, 2026
FEI 3014534490Westland, MI1Jan 22, 2026
FEI 3014574626Joliet, IL1Jan 8, 2026
FEI 1876550Tampa, FL5Dec 31, 2025
FEI 3027084956Bradley, IL1Dec 18, 2025
FEI 3030150780Ponce, PR1Dec 12, 2025
FEI 3024034256North Miami, FL1Dec 11, 2025
FEI 3013949443Montgomery, IL1Dec 4, 2025
FEI 3014028623Rockford, IL1Dec 4, 2025
FEI 3015886607District Heights, MD1Dec 1, 2025
FEI 3027406332Chicago, IL1Nov 21, 2025
FEI 3017502454Allentown, PA2Oct 10, 2025
FEI 3015256241Chicago, IL1Oct 9, 2025
FEI 2171832Canton, OH7Sep 9, 2025
FEI 3012267107Grand Junction, CO2Aug 7, 2025
FEI 1978022Springfield, MO6Jul 30, 2025
FEI 3011816262Philadelphia, PA4Jul 28, 2025
FEI 1000118555Norman, OK5Jul 17, 2025
FEI 3010978862Montgomery, AL2Jul 17, 2025
FEI 3012539079Kent, OH2Jun 30, 2025
FEI 3010719422Tampa, FL2Mar 28, 2025
FEI 3011813573Philadelphia, PA3Mar 27, 2025
FEI 1930460Kansas City, MO7Mar 21, 2025
FEI 3005600077Hamilton, OH6Mar 4, 2025
FEI 2177738Minneapolis, MN6Feb 26, 2025
FEI 1000118483Manhattan, KS6Feb 14, 2025
FEI 3011893716Columbus, OH2Feb 13, 2025
FEI 3011511768Glen Burnie, MD4Feb 12, 2025
FEI 1972445Kansas City, MO7Feb 6, 2025
FEI 3013942381Muncie, IN1Jan 31, 2025
FEI 3011144678Winston Salem, NC2Jan 30, 2025

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