Quva Pharma, Inc.
FDA 503B outsourcing facility
Bloomsbury, New Jersey
Key Takeaways
- FDA-registered 503B outsourcing facility since 2017
- Sterile compounding from bulk substances: Yes
- Last FDA inspection: April 4, 2025
- 37 FDA drug recalls on record (2016 to 2025)
About this facility
A 503B outsourcing facility is registered with the FDA under the Drug Quality and Security Act and may compound sterile medications in bulk without patient-specific prescriptions, under cGMP manufacturing standards. How federal compounding status works.
FDA registration and inspection record
- First registered with FDA
- September 15, 2017
- Most recent registration
- December 4, 2025
- Compounds sterile drugs from bulk substances
- Yes
- Last FDA inspection
- April 4, 2025
The FDA last inspected Quva Pharma, Inc. on April 4, 2025. Investigators issued a Form FDA 483 listing inspectional observations at that visit. The FDA has not yet determined whether further action will be taken.
FDA recall history
Quva Pharma, Inc. has 37 FDA drug recalls on record between 2016 and 2025, based on the FDA enforcement database. Breakdown: 2 Class I, 32 Class II, 3 Class III.
Recall reasons on record include presence of particulate matter; lack of assurance of sterility; incorrect product formulation: oxytocin 30 units was added to an iv bag of 0.45% sodium; subpotent drug - product did not contain drug; presence of particulate matter: fresenius kabi recalling vials of ketorolac.
| Date | Class | Product | Reason |
|---|---|---|---|
| October 2025 | Class II | R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe. | Presence of Particulate Matter |
| March 2025 | Class II | fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection f | Lack of Assurance of Sterility |
| March 2025 | Class II | fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Ep | Lack of Assurance of Sterility |
| March 2025 | Class II | fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Ep | Lack of Assurance of Sterility |
| September 2022 | Class III | oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride, Injection for IV Use, High Alert, This is a Compounded Product for I | Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL). |
Showing the 5 most recent of 37 recall events.
FDA recall classes signal severity, not intent: Class I means a reasonable probability of serious harm, Class II a temporary or reversible risk, Class III a violation unlikely to cause harm. Sterile compounders routinely recall lots as a precaution. FDA definitions.
What this facility compounds
Quva Pharma, Inc. reports compounding 53 distinct active ingredients to the FDA Outsourcing Facility Product Report (most recent reporting periods).
Tracked on PeptideGrids: Oxytocin.
- Acetaminophen
- Amiodarone
- Amiodarone Hydrochloride
- Atropine Sulfate
- Bupivacaine Hydrochloride
- Bupivacaine Hydrochloride Anhydrous; Fentanyl Citrate
- Cefazolin
- Cefazolin Sodium
- Dextrose Monohydrate
- Diltiazem Hydrochloride
- Ephedrine Hydrochloride
- Ephedrine Sulfate
- Epinephrine
- Fentanyl
- Fentanyl Citrate
- Fentanyl Citrate; Bupivacaine Hydrochloride
- Fentanyl Citrate; Bupivacaine Hydrochloride Anhydrous
- Fentanyl Citrate; Ropivacaine Hydrochloride
- Heparin
- Heparin Sodium
- Hydromorphone Hydrochloride
- Ketamine
- Ketamine Hydrochloride
- Ketorolac Tromethamine; Epinephrine; Clonidine Hydrochloride; Ropivacaine Hydrochloride
- Labetalol
- Labetalol Hydrochloride
- Lidocaine
- Lidocaine Hydrochloride
- Lidocaine Hydrochloride Anhydrous; Tetracaine Hydrochloride; Epinephrine Hydrochloride
- Lidocaine Hydrochloride; Epinephrine
and 23 more.
Location
1075 W Park One Dr Ste 100, N/A, Sugar Land, TX 77478-2576
Satellite and street imagery via Esri. Open larger map.
Contact
FDA-registered contact: David Short, 1-908-388-1079. Source: the facility's FDA outsourcing registration.
License verification
503B outsourcing facilities are also licensed by the state board of pharmacy. Verify the current license status of Quva Pharma, Inc. with the New Jersey Board of Pharmacy.
503B facilities in New Jersey
Quva Pharma, Inc. also operates a registered 503B facility at Sugar Land, TX.
New Jersey has 10 FDA-registered 503B outsourcing facilities in the PeptideGrids directory. See all 503B facilities in New Jersey.
Frequently asked questions
Is Quva Pharma, Inc. registered with the FDA?
Yes. Quva Pharma, Inc. is a registered 503B outsourcing facility, first registered with the FDA on September 15, 2017 and most recently registered on December 4, 2025.
Has Quva Pharma, Inc. been inspected by the FDA?
The FDA last inspected Quva Pharma, Inc. on April 4, 2025. A Form FDA 483 was issued.
Has Quva Pharma, Inc. had any FDA drug recalls?
Quva Pharma, Inc. has 37 FDA drug recalls on record (2016 to 2025) in the FDA enforcement database.
What does Quva Pharma, Inc. compound?
Quva Pharma, Inc. reports compounding 53 active ingredients to the FDA, including Oxytocin.
Where is Quva Pharma, Inc. located?
Quva Pharma, Inc. is located in Bloomsbury, New Jersey (1075 W Park One Dr Ste 100).
Registration and inspection data verified against the FDA list of registered outsourcing facilities on June 6, 2026. Recall history from the FDA openFDA drug enforcement database, retrieved June 6, 2026.
PeptideGrids is independent and not affiliated with, endorsed by, or sponsored by Quva Pharma, Inc.. Listings, registration, inspection, and recall data are reported from public FDA records for informational purposes only. A recall or inspection finding is not an accusation of current wrongdoing. This is not medical or legal advice. To request a correction, see our corrections policy.