Entity monitoring profile
QuVa Pharma Verification and Monitoring Profile
Federal 503B registration status for QuVa Pharma, checked against the complete FDA register, with the open fields that remain.
QuVa Pharma appears on FDA's registered outsourcing facility list under two registered site entries: Quva Pharma, Inc. (Bloomsbury, NJ), Quva Pharma, Inc. (Sugar Land, TX). Registration is a federal filing, not FDA approval, and not a finding of CGMP compliance. FDA's register records inspections at 2 facilities under this name, most recently 2026-05-04, with a Form 483 issued at 1 of them. A Form 483 records investigator observations, not a final agency finding.
Key findings
- Federal 503B registration: Registered 503B outsourcing facility.
- Two registered sites. FDA inspects facilities individually, so a record at one site does not describe the other.
- Registration means FDA received the required filing — it is not approval and not a CGMP finding.
- FDA inspection records are published below for 2 registered facilities; a Form 483 lists observations, not findings.
- Checked against the complete FDA register of 96 outsourcing facility registrations.
| Entity name as published | QuVa Pharma |
|---|---|
| Federal 503B registration | 503B Registration Verified Registered 503B outsourcing facility |
| Registered site(s) on FDA list |
|
| Registry checked against | 96 registrations, FDA list, 2026-07-23 |
| Operating model | Widely identified as a registered 503B outsourcing facility; registration to be confirmed against the current FDA list. |
| State licence and number | Verification Pending |
| Nonresident licences | Verification Pending |
| FDA inspection history | License Verified most recent 2026-05-04 across 2 registered facilities |
| Form 483 observations | Official Action Form 483 issued at 1 of 2 facilities — investigator observations, not a final finding |
| Warning letters | No Public Evidence Found no warning letter recorded in the FDA register |
| Most recent action status | Response Received Bloomsbury, NJ: Open; Sugar Land, TX: Open |
| Recalls (current) | Verification Pending |
| Recalls (historical) | Verification Pending |
| State disciplinary records | Verification Pending |
| Accreditations | Verification Pending |
| Ownership | Verification Pending |
Federal registration status
Two registered sites. FDA inspects facilities individually, so a record at one site does not describe the other.
Registration and inspections are facility specific. Facilities under common ownership and control are inspected individually. Before purchasing, FDA advises determining that the specific facility in which the drugs are compounded is an outsourcing facility with a satisfactory inspection. FDA
| Registered facility name | Location |
|---|---|
| Quva Pharma, Inc. | Bloomsbury, NJ |
| Quva Pharma, Inc. | Sugar Land, TX |
What this means
- QuVa Pharma holds 2 registration entries on FDA's published list.
- The registered legal name and site location are stated as published by FDA.
- Registration and inspection are facility specific, so each site stands alone.
What this does not mean
- That this entity is compliant, safe, or non-compliant — none is asserted.
- That federal registration constitutes approval or a CGMP finding.
- That registration indicates a satisfactory inspection — FDA states it does not.
FDA inspection record for QuVa Pharma
FDA publishes inspection information per facility at the listed address. QuVa Pharma has 2 registered facilities on the register, and the record below is reproduced from FDA's published columns as captured on 2026-07-23.
FDA states that 'Closed' means an inspection was closed without further action and 'Open' means FDA has not made a determination as to whether further action will be taken. Inspection information applies to the facility at the listed address, and one company may operate several registered facilities with different histories.
| Registered facility | Location | Most recent inspection | Form 483 issued | Action | Detail |
|---|---|---|---|---|---|
| Quva Pharma, Inc. | Bloomsbury, NJ | 2025-04-04 | Yes | Open | FDA has not determined whether further action will be taken |
| Quva Pharma, Inc. | Sugar Land, TX | 2026-05-04 | No | Open | FDA has not determined whether further action will be taken |
What this means
- FDA has inspected 2 registered facilities operating under this name.
- The inspection date, Form 483 issuance and action status are reproduced as FDA publishes them.
- Each facility record stands alone, because FDA inspects facilities individually.
What this does not mean
- That a Form 483 is a final agency finding — it records investigator observations.
- That an 'Open' status is an adverse finding — it means no determination has yet been made.
- That this record covers 503A pharmacies, state licensure, or any facility not on the federal register.
What can and cannot be established about QuVa Pharma today?
Verification of a compounding entity runs across two separate systems that do not talk to each other. The federal system covers outsourcing facilities only: registration, CGMP inspection, Form 483 observations, warning letters and recalls. The state system covers licensure, scope of permitted compounding, and discipline — and it is the only system that covers 503A pharmacies at all.
For QuVa Pharma, the federal side is settled at this snapshot: registered 503b outsourcing facility. The state side is not, and that is where the remaining evidentiary weight sits.
| Question | System that answers it | Status for this entity |
|---|---|---|
| Is it federally registered as a 503B facility? | FDA outsourcing facility register | 503B Registration Verified |
| Is its state pharmacy licence current? | State board of pharmacy | Verification Pending |
| Is it permitted to compound sterile preparations? | State board permit class | Verification Pending |
| Has FDA inspected it, and what was found? | FDA inspection records | Verification Pending |
| Are there Form 483 observations? | FDA inspection records | Verification Pending |
| Is there an active warning letter? | FDA warning letter database | Verification Pending |
| Any current or historical recalls? | FDA enforcement reports | Verification Pending |
| Any state disciplinary action? | State board orders | Verification Pending |
Why 2 separate entries matter
QuVa Pharma appears 2 times on the federal register because registration is per facility, not per company. Registration and inspections are facility specific. Facilities under common ownership and control are inspected individually. Before purchasing, FDA advises determining that the specific facility in which the drugs are compounded is an outsourcing facility with a satisfactory inspection. FDA
The practical consequence is that a finding at one site — an inspection outcome, a 483, a recall — describes that site and not the others. Reporting a company-level conclusion from a single-facility record is one of the most common errors in this sector, and this platform does not make it.
What a buyer should do with this record
This page settles one question and names the records that settle the rest. It is a starting point for verification, not a substitute for it.
If a programme names QuVa Pharma as its dispensing pharmacy, the next step is the state board register — that confirms whether the licence is current today, which no snapshot can. Then, if a 503B claim is made, confirm it against the FDA register directly rather than accepting the claim.
FDA inspection record, facility by facility
FDA publishes inspection information per facility at the listed address. QuVa Pharma has 2 registered facilities on the register, and the record below reproduces FDA's published columns as captured 2026-07-23.
Two terms carry specific meanings and are routinely misreported. A Form 483 lists observations made by the investigator at the close of an inspection — it is not a final agency determination, and the firm has an opportunity to respond. An action status of ‘Open’ means FDA has not yet decided whether further action will be taken; it records the absence of a decision, not the presence of a finding.
Registration and inspections are facility specific. Facilities under common ownership and control are inspected individually. Before purchasing, FDA advises determining that the specific facility in which the drugs are compounded is an outsourcing facility with a satisfactory inspection. FDA
| Registered facility | Location | Most recent inspection | Form 483 issued | Action | Detail |
|---|---|---|---|---|---|
| Quva Pharma, Inc. | Bloomsbury, NJ | 2025-04-04 | Yes | Open | FDA has not determined whether further action will be taken |
| Quva Pharma, Inc. | Sugar Land, TX | 2026-05-04 | No | Open | FDA has not determined whether further action will be taken |
What this means
- FDA inspected 2 registered facilities on the dates shown.
- Where a Form 483 was issued, the investigator recorded observations at that inspection.
- Where a warning letter was issued, FDA has stated a position on specific violations.
What this does not mean
- That any observation has been adjudicated as a violation — a 483 is not a finding.
- That an ‘Open’ status indicates wrongdoing; it records no decision either way.
- That a record at one facility describes another under the same ownership.
- Sourced from FDA's published table as captured 2026-07-23; FDA updates it weekly.
- Form 483 content is not published in this table — only whether one was issued.
- Warning letter closeout status is not shown in this table and is not established here.
- Recall history is not covered by this table and remains unverified for this entity.
- State board inspection and disciplinary records are separate and are not covered here.
Source for these inspection records — 1 source
- FDA Registered Outsourcing Facilities tablechecked 2026-07-23
What remains open for QuVa Pharma
QuVa Pharma's federal register position is settled at this snapshot. What is not settled is everything held by state boards: the licence itself, its number and expiry, nonresident licensure, and any disciplinary record. Those sit with the board in each state where it operates.
To determine whether a registered outsourcing facility has been the subject of a state enforcement action, FDA directs the public to check with the State Board of Pharmacy for the state in which the facility is located. FDA
The method used for each field, and why none of it can be inferred, is set out on the methodology page. Sector-level context on the gap between registration and inspection is on the monitoring hub.
- Checked against FDA's register of 96 registrations on 2026-07-23; FDA updates the list weekly.
- Self-reported registration information on FDA's list has not been verified by FDA.
- State licensure, inspection outcomes and enforcement records have not been checked for this entity.
- Sector statistics describe the 503B population, not this entity.
Sources checked for this entity — 5 sources
- FDA Registered Outsourcing Facilities listchecked 2026-07-23
- FDA — Information for Outsourcing Facilitieschecked 2026-07-23
- FDA — Q&A: Outsourcing Facility Registrationchecked 2026-07-23
- FDA — Registered Outsourcing Facilitieschecked 2026-07-23
- FDA — Aligning Federal and State Regulation of Compounderschecked 2026-07-23
Related records in this section
Section hub: Pharmacy profiles · Methodology · Status definitions · Right to respond
Frequently asked questions
Is QuVa Pharma a registered 503B outsourcing facility?
Yes. It appears on FDA's register as Quva Pharma, Inc. (Bloomsbury, NJ), Quva Pharma, Inc. (Sugar Land, TX).
How many registered sites does QuVa Pharma operate?
2 appear on the current list. FDA inspects facilities individually, so a record at one site does not describe another.
Does registration mean FDA approved QuVa Pharma?
No. Registration means FDA received the required filing and the annual establishment fee was paid. It is not approval and not a finding of CGMP compliance.
Has QuVa Pharma been inspected by FDA?
Not verified on this page. FDA publishes inspection dates and status on its register; sector-wide, a substantial share of newly registered facilities had not been inspected as of July 2025.
Can QuVa Pharma still compound semaglutide or tirzepatide?
Both shortages are resolved and FDA proposed on 30 April 2026 to exclude both from the 503B bulks list, restricting bulk compounding by outsourcing facilities. Narrow patient-specific 503A compounding may remain available. This page assesses no entity's compliance.
Does this page allege anything about QuVa Pharma?
No. It reports federal register status with its source and date, and lists what remains unverified. No violation, finding, or concern is asserted.
Sources
- FDA Registered Outsourcing Facilities list
- FDA — Information for Outsourcing Facilities
- FDA — Q&A: Outsourcing Facility Registration
- FDA — Registered Outsourcing Facilities
- FDA — Aligning Federal and State Regulation of Compounders
Update history
| Date | Change |
|---|---|
| 2026-07-23 | Record published at current snapshot. |
Dates change only for substantive updates. Entities may submit a correction or response through the right-to-respond process.