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FDA record · 503B inspections · updated Sep 2026

55 of 56 inspected 503B facilities got a Form FDA 483 at their last inspection, as of September 2026

Julian CaraulaniFounder, PriceTracker GLP-1Source read October 2026

55 of 56

inspected 503B facilities issued a Form 483

55 of the 56 503B outsourcing facilities FDA has inspected (98%) were issued a Form FDA 483 at their most recent inspection, according to FDA's Registered Outsourcing Facilities table updated September 30, 2026.

FDA table updated · read by us

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Key findings

  1. 55 of the 56 registered 503B facilities with a published inspection date (98%) were issued a Form FDA 483 at their most recent inspection.
  2. For 38 of the 56, FDA lists the inspection as "Open": FDA has not determined whether further action will be taken.
  3. 6 list a warning letter as the action based on the last inspection; 0 list a recall.
  4. 33 of the 56 were the subject of at least one earlier compounding inspection that ended in a Form 483, warning letter or other action.
  5. 26 of the 56 last inspections took place in 2026.

The numbers, to scale

What FDA lists as the action after the last inspection
  1. Open38
  2. Regulatory meeting held6
  3. Warning letter6
  4. Untitled letter2
  5. FMD-145 letter4

56 inspected facilities, grouped by FDA's "Action Based on Last Inspection" column. Source: FDA register updated September 30, 2026.

Every inspected facility (56), most recent inspection first

Form FDA 483s at 503B outsourcing facility inspections
FacilityLocationLast inspectionForm 483FDA action listedRecall
Leesar Inc.Fort Myers, FLYesOpenNo
Assure Infusions, Inc.Bartow, FLYesOpenNo
STAQ Pharma, Inc.Denver, COYesOpenNo
Olympia PharmaceuticalsOrlando, FLYesOpenNo
RC Outsourcing, LLCLowellville, OHYesOpenNo
Apothecary Pharma, LLCCary, NCYesOpenNo
Tailstorm Health Inc.Chandler, AZYesOpenNo
Hybrid Pharma, LLCDeerfield Beach, CAYesOpenNo
STAQ Pharma of Ohio, LLCColumbus, OHYesOpenNo
Imprimis NJOF, LLCLedgewood, NJYesOpenNo
Apollo CareColumbia, MOYesOpenNo
Brookfield Medical/Surgical Supply, Inc.Brookfield, CTYesOpenNo
Annovex Pharma, Inc.Lorton, VAYesOpenNo
PQ Pharmacy LLCBrooksville, FLYesOpenNo
SKNV formerly registered as Sincerus Florida, LLCPompano Beach, FLYesOpenNo
Turbare ManufacturingConway, ARYesOpenNot published
Quva Pharma, Inc.Sugar Land, TXYesOpenNo
BPI Labs LLCLargo, FLYesOpenNo
Wells Pharma of Houston, LLCHouston, TXYesOpenNo
Wells Pharmacy, Inc.Dyersburg, TNYesOpenNo
Wesley PharmaceuticalsOrlando, FLNoFMD-145 Letter Issued 6/17/2026No
SCA PharmaceuticalsWindsor, CTYesOpenNo
BayCare Integrated Service Center, LLC dba BayCare Central PharmacyTemple Terrace, FLYesFMD-145 Letter Issued 9/18/2023No
Staska Pharmaceuticals, Inc.Bennet, NEYesOpenNo
Mark Cuban Cost Plus Manufacturing and Compounding, LLCDallas, TXYesFMD-145 Letter Issued 6/5/2025No
US Specialty Formulations LLCAllentown, PAYesOpenNo
F.H. Investments, Inc.Birmingham, ALYesOpenNo
Denver Solutions, LLC, dba Leiters HealthEnglewood, COYesUntitled Letter Issued 6/8/2026No
Nubratori, Inc.Torrance, CAYesWarning Letter Closeout Issued 7/27/2026 FMD-145 Letter Issued 7/21/2026No
Delta Pharma, Inc.Ripley, MSYesOpenNo
Empower PharmaHouston, TXYesOpenNo
OSRX, Inc.Missoula, MTYesOpenNo
Pine Pharmaceuticals, LLCTonawanda, NYYesWarning Letter Issued 8/7/2026No
Fresenius Kabi Compounding LLC dba Fagron Sterile ServicesCanton, MAYesWarning Letter Issued 5/12/2026No
SCA PharmaceuticalsLittle Rock, ARYesWarning Letter Issued 9/14/2026No
Park Avenue CompoundingSt. Louis, MOYesRegulatory Meeting Held 5/7/2026No
ProRx LLCExton, PAYesWarning Letter Issued 4/7/2026No
Central Admixture Pharmacy ServicesPhoenix, AZYesRegulatory Meeting Held 5/5/2026No
Central Admixture Pharmacy Services, Inc.Allentown, PAYesRegulatory Meeting Held 5/5/2026No
Farmakeio Outsourcing LLCSouthlake, TXYesOpenNo
Qualgen LLCEdmond, OKYesOpenNo
Nephron Sterile Compounding Center, LLC (NSCC)West Columbia, SCYesOpenNo
Molecular PharmaGroupNew Providence, NJYesUntitled Letter Issued 2/5/2026No
AnazaoHealth CorporationLas Vegas, NVYesOpenNo
Fagron Compounding Services dba Fagron Sterile ServicesWichita, KSYesRegulatory Meeting Held 2/27/2026No
GenoGenix LLCRaton, FLYesOpenNot published
Right Value Drug Stores, LLC, dba Carie Boyd's Prescription ShopIrving, TXYesRegulatory Meeting Held 1/8/2026No
BSO LLCLakewood, COYesRegulatory Meeting Held 3/3/2026No
Wedgewood Connect, LLC, formerly registered as Leiter's CompoundingSan Jose, CAYesOpenNo
BSO LLCGolden, COYesOpenNot published
MedisourceRxLos Alamitos, CAYesWarning Letter Closeout Issued 7/27/2026 Warning Letter Issued 12/12/2025No
Medi-Fare DrugBlacksburg, SCYesOpenNo
Stokes Healthcare Inc., dba Epicur PharmaMt. Laurel, NJYesOpenNo
Quva Pharma, Inc.Bloomsbury, NJYesOpenNo
Eagle PharmaBirmingham, ALYesOpenNo
OurPharma LLCFayetteville, ARYesFMD-145 Letter Issued 6/23/2025No

Copied from FDA's table as updated September 30, 2026. A Form 483 lists investigators' observations; it is not a final agency determination. All 56 rows, with every column, are in the CSV and JSON.

How the number is computed

Facilities with a date in FDA's "Last Inspection" column are the denominator. The numerator is those whose "Form 483 Issued?" cell reads "Yes", plus 4 where FDA's cell is a link to the Form 483 itself (it reads "483").

Included

  • Every facility on FDA's 503B table with a published last-inspection date.

Excluded

  • Facilities marked "Not yet inspected".
  • Earlier inspections: FDA's table shows the most recent inspection only (a flag marks facilities with prior actions).

Read it with care

  • A Form 483 records observations; it is not a finding that the law was broken.
  • "Open" means FDA has not yet decided whether to act, not that a problem is unresolved.
  • Inspection dates are FDA's: the day the Form 483 was issued, or the last day of the inspection when none was.

Receipts

2 sources · read October 3, 2026

  1. 01read

    A Form FDA 483 is issued when investigators observe any significant objectionable conditions. It does not constitute a final agency determination of whether any condition is in violation of the FD&C Act or any relevant regulations.

    FDA, Registered Outsourcing Facilities (503B), updated September 30, 2026
  2. 02read

    “Closed” means the inspection has been closed without further action. “Open” means FDA has not determined whether further action will be taken. If an action has been taken, it will be listed.

    FDA, Registered Outsourcing Facilities (503B), updated September 30, 2026

Cite this

Free to reuse under CC BY 4.0: quote the number, credit PriceTracker GLP-1 with a link, and name the federal source. The underlying records are public; our counts, matching and files are the work you are crediting.

Citation (APA)
PriceTracker GLP-1. (2026, October 3). Form FDA 483s at 503B outsourcing facility inspections [Data set]. Based on U.S. Food and Drug Administration data, fda table updated September 30, 2026. https://pricetrackerglp1.com/data/503b-inspection-findings
Sentence with link (HTML)
<p>55 of the 56 503B outsourcing facilities FDA has inspected (98%) were issued a Form FDA 483 at their most recent inspection, according to FDA's Registered Outsourcing Facilities table updated September 30, 2026. Source: <a href="https://pricetrackerglp1.com/data/503b-inspection-findings">PriceTracker GLP-1</a> (CC BY 4.0).</p>
Data files
https://pricetrackerglp1.com/data/503b-inspection-findings.csv
https://pricetrackerglp1.com/data/503b-inspection-findings.json
503B facilities not yet inspected42 of 98 503B outsourcing facilities not yet inspectedGLP-1 warning letters, last 12 months78 GLP-1 warning letters, Oct 2025 to Oct 2026Telehealth programs with an FDA warning letter5 of 37 tracked programs with an FDA warning letterMedicaid GLP-1 prescriptions by state, 202511.26 million Medicaid GLP-1 prescriptions, 2025Medicaid GLP-1 spending by state, 2025$11.8B Medicaid GLP-1 reimbursement, 2025, before rebatesMedicare Part D GLP-1 spending, 2024$27.5B Part D GLP-1 spending, 2024, before rebates