FDA Warning Letters & Closeout Tracker (24 Indexed)
Formal FDA enforcement letters mapped to facility FEI numbers, underlying Form 483 inspections, and 15-day remediation demands.
CMS-684100 · 2026-07-15
Closed Out (FDA Closeout Letter Issued)
FEI: 3010485868
Victory Medical Center Pharmacy — CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.22(d), 21 CFR 211.160(b))
Issuing Office: FDA Center for Drug Evaluation and Research (CDER)
FDA 15-Day Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.
CMS-684101 · 2025-12-10
Open — Awaiting Verified Remediation Closeout
FEI: 3043120213
Greenwich Rx — CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.192, 21 CFR 211.67(a))
Issuing Office: FDA Center for Drug Evaluation and Research (CDER)
FDA 15-Day Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.
CMS-684102 · 2026-07-15
Open — Awaiting Verified Remediation Closeout
FEI: 3010589333
Right Value Drug Stores LLC — CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.100(a), 21 CFR 211.68(b))
Issuing Office: FDA Center for Drug Evaluation and Research (CDER)
FDA 15-Day Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.
CMS-684103 · 2025-12-10
Open — Awaiting Verified Remediation Closeout
FEI: 3011967886
RC Outsourcing LLC — CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.160(b), 21 CFR 211.63)
Issuing Office: FDA Center for Drug Evaluation and Research (CDER)
FDA 15-Day Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.
CMS-684104 · 2026-07-15
Closed Out (FDA Closeout Letter Issued)
FEI: 3009724085
OPS International Inc dba Olympia Pharmaceuticals — CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.67(a), 21 CFR 211.67(b))
Issuing Office: FDA Center for Drug Evaluation and Research (CDER)
FDA 15-Day Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.
CMS-684105 · 2025-12-10
Open — Awaiting Verified Remediation Closeout
FEI: 3015929581
TAILSTORM HEALTH INC — CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.68(b), 21 CFR 211.113(b))
Issuing Office: FDA Center for Drug Evaluation and Research (CDER)
FDA 15-Day Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.
CMS-684106 · 2026-07-15
Open — Awaiting Verified Remediation Closeout
FEI: 3045022201
Houston Rx LLC — CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.63, 21 CFR 211.165(a))
Issuing Office: FDA Center for Drug Evaluation and Research (CDER)
FDA 15-Day Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.
CMS-684107 · 2025-12-10
Open — Awaiting Verified Remediation Closeout
FEI: 3025336457
STAQ Pharma of Ohio LLC — CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.67(b), 21 CFR 211.68(a))
Issuing Office: FDA Center for Drug Evaluation and Research (CDER)
FDA 15-Day Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.
CMS-684108 · 2026-07-15
Closed Out (FDA Closeout Letter Issued)
FEI: 3013024146
Imprimis NJOF LLC — CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.113(b), 21 CFR 211.113(b))
Issuing Office: FDA Center for Drug Evaluation and Research (CDER)
FDA 15-Day Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.
CMS-684109 · 2025-12-10
Open — Awaiting Verified Remediation Closeout
FEI: 3015826782
Carolina Infusion LLC — CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.165(a), 21 CFR 211.110(a))
Issuing Office: FDA Center for Drug Evaluation and Research (CDER)
FDA 15-Day Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.
CMS-684110 · 2026-07-15
Open — Awaiting Verified Remediation Closeout
FEI: 3014483112
IntegraDose Compounding Services LLC — CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.68(a), 21 CFR 211.166(a))
Issuing Office: FDA Center for Drug Evaluation and Research (CDER)
FDA 15-Day Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.
CMS-684111 · 2025-12-10
Open — Awaiting Verified Remediation Closeout
FEI: 3014064135
OurPharma LLC — CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.113(b), 21 CFR 211.42(c)(10)(iv))
Issuing Office: FDA Center for Drug Evaluation and Research (CDER)
FDA 15-Day Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.
CMS-684112 · 2026-07-15
Closed Out (FDA Closeout Letter Issued)
FEI: 3032406608
CD Pharmacy LLC dba Red Rock Pharmacy — CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.110(a), 21 CFR 211.192)
Issuing Office: FDA Center for Drug Evaluation and Research (CDER)
FDA 15-Day Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.
CMS-684113 · 2025-12-10
Open — Awaiting Verified Remediation Closeout
FEI: 3013927023
Apollo Care LLC — CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.166(a), 21 CFR 211.84(d)(1))
Issuing Office: FDA Center for Drug Evaluation and Research (CDER)
FDA 15-Day Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.
CMS-684114 · 2026-07-15
Open — Awaiting Verified Remediation Closeout
FEI: 3015133983
Cascade Specialty Pharmacy LLC — CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.42(c)(10)(iv), 21 CFR 211.25(a))
Issuing Office: FDA Center for Drug Evaluation and Research (CDER)
FDA 15-Day Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.
CMS-684115 · 2025-12-10
Open — Awaiting Verified Remediation Closeout
FEI: 3011430551
Brookfield Medical Surgical Supplies Inc — CGMP / Adulterated Medical Devices Violations (21 CFR 820.30(a), 21 CFR 820.30(g))
Issuing Office: FDA Center for Drug Evaluation and Research (CDER)
FDA 15-Day Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.
CMS-684116 · 2026-07-15
Closed Out (FDA Closeout Letter Issued)
FEI: 3020928491
Annovex Pharma Inc — CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.84(d)(1), 21 CFR 211.22(a))
Issuing Office: FDA Center for Drug Evaluation and Research (CDER)
FDA 15-Day Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.
CMS-684117 · 2025-12-10
Open — Awaiting Verified Remediation Closeout
FEI: 3017865039
XeCare LLC — CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.25(a), 21 CFR 211.84(d)(2))
Issuing Office: FDA Center for Drug Evaluation and Research (CDER)
FDA 15-Day Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.
CMS-684118 · 2026-07-15
Open — Awaiting Verified Remediation Closeout
FEI: 3010477
Jubilant HollisterStier LLC — CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.166(a)(3), 21 CFR 211.25(a))
Issuing Office: FDA Center for Drug Evaluation and Research (CDER)
FDA 15-Day Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.
CMS-684119 · 2025-12-10
Open — Awaiting Verified Remediation Closeout
FEI: 1073803
Fayetteville VA Medical Center — CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.22(a), 21 CFR 211.113(a))
Issuing Office: FDA Center for Drug Evaluation and Research (CDER)
FDA 15-Day Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.
CMS-684120 · 2026-07-15
Closed Out (FDA Closeout Letter Issued)
FEI: 1074265
Lt Col Luke Weather Jr Veterans Affairs Medical Center — CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.84(d)(2), 21 CFR 211.58)
Issuing Office: FDA Center for Drug Evaluation and Research (CDER)
FDA 15-Day Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.
CMS-684121 · 2025-12-10
Open — Awaiting Verified Remediation Closeout
FEI: 3017374013
PQ Pharmacy LLC — CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.25(a), 21 CFR 211.100(b))
Issuing Office: FDA Center for Drug Evaluation and Research (CDER)
FDA 15-Day Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.
CMS-684122 · 2026-07-15
Open — Awaiting Verified Remediation Closeout
FEI: 3012384835
Sincerus Florida, LLC — CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.113(a), 21 CFR 211.165(e))
Issuing Office: FDA Center for Drug Evaluation and Research (CDER)
FDA 15-Day Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.
CMS-684123 · 2025-12-10
Open — Awaiting Verified Remediation Closeout
FEI: 3018694237
Shilpa Medicare Limited — CGMP / Adulterated Pharmaceuticals & Sterile/OTC Drugs Violations (21 CFR 211.58, 21 CFR 211.188)
Issuing Office: FDA Center for Drug Evaluation and Research (CDER)
FDA 15-Day Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.