KRS Global Biotechnology, Inc

FDA Regulatory Profile

KRS Global Biotechnology, Inc has 129 FDA recalls, 4 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest recall
D-0047-2020 · Class II · Sep 12, 2019
Latest inspection
Aug 14, 2019 · OAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls129Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections4Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
D-0047-2020Class IIePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 25 mg/5 mL (5 mg/mL) 5 mL Fill in a 6 mL Syringe…Sep 12, 2019
D-0093-2020Class IISermorelin Acetate, 9 mg / GHRP-2, 5.4 mg/vial Lyophilized-for SC Use, Rx Only, KRS Global…Sep 12, 2019
D-0051-2020Class IIfentaNYL Citrate in 0.9% Sodium Chloride (PF) 2,500 mcg/100 mL (25 mcg/mL) 100 mL Fill in 150 mL IV…Sep 12, 2019
D-0098-2020Class IISermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park…Sep 12, 2019
D-0100-2020Class IISermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology…Sep 12, 2019
D-0061-2020Class IIHydroxocobalamin 10 mL Vial 5 mg/10 mL (0.5 mg/mL) For IM Use, Rx Only, KRS Global Biotechnology 791…Sep 12, 2019
D-0039-2020Class IIAlpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vial for IV Use, Rx Only, KRS…Sep 12, 2019
D-0071-2020Class IILIDOcaine 2% (20 mg/mL)/Bupivacaine 0.375% (3.75 mg/mL)/ Hyaluronidase 3 U/mL (PF) Ophthalmic…Sep 12, 2019
D-0053-2020Class IIGlutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL) Rx Only, KRS…Sep 12, 2019
D-0041-2020Class IIAscorbic Acid (Tapioca Source) 25 g/50 mL (0.5 g/mL) 50 mL Vial--For SC/IM Use-Contains Sulfites, Rx…Sep 12, 2019
D-0113-2020Class IIVitamin 9 Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd…Sep 12, 2019
D-0096-2020Class IISermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized, Rx Only, KRS Global…Sep 12, 2019
D-0043-2020Class IIBimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate 3 mg/mL) in 5 mL Vial, Rx Only, KRS Global…Sep 12, 2019
D-0052-2020Class IIFluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial, Rx Only, KRS Global…Sep 12, 2019
D-0114-2020Class IIVitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce…Sep 12, 2019
D-0090-2020Class IIPolidocanol 5%, 500 mg / 10 mL (50 mg/mL), 10 mL Vial for IV Use, Rx Only, KRS Global Biotechnology…Sep 12, 2019
D-0111-2020Class IIVitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use, Rx Only, KRS Global Biotechnology 791…Sep 12, 2019
D-0110-2020Class IIVitamin 10 B Lyophilized, Vial, For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce…Sep 12, 2019
D-0117-2020Class IIL-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC Use, Rx Only, KRS…Sep 12, 2019
D-0081-2020Class IINORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL),Rx Only, KRS…Sep 12, 2019

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 14, 2019Boca Raton, FLDrugsOfficial Action Indicated (OAI)3006412304
Oct 23, 2017Boca Raton, FLDrugsVoluntary Action Indicated (VAI)3006412304
Aug 31, 2016Boca Raton, FLDrugsVoluntary Action Indicated (VAI)3006412304
Mar 17, 2014Boca Raton, FLDrugsOfficial Action Indicated (OAI)3006412304

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 3006412304Boca Raton, FL4Aug 14, 2019

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