Key facts
| Firm | QuVa Pharma Inc |
|---|---|
| FEI / inspection ID | 3012053582 |
| Inspection end date | October 28, 2024 |
| Citation count | 4 |
Citations explained
Observation 1 — Procedm es designed to prevent microbiological contamination of diug products pmp o1ting
Procedm es designed to prevent microbiological contamination of diug products pmp o1ting to be sterile are not followe d. Specifically, for example: A. Dur ing a review of your firm's incident reports ( !Rs) since the previous FDA inspection, y our firm fai led to adequately investi gate the fo llowing doc umented events: 1. Your firm doc umented 10 - 2024 !Rs and 19 - 2023 !Rs of 6,(4 for ISO 5 BSC/ LAFU " Hood Cleaning contact time discrepancy" for use of y our firm's disi nfectant agent , [{6 )(-4) I less than [(6)(-4) I per manufacturer specification to disi nfect surfaces with in your firm's ISO 5 BSC/ LAFU used in the aseptic processing of sterile drug products. Your firm's documented root cause was " Personnel Error" . Your firm 's doc umented correct ive act ion for the root cause to prevent recurrence was to conduct emplo yee train ing. Your firm's i nvesti gation.
Observation 2 — Complaint records are deficient in that they do n ot include the
Complaint records are deficient in that they do n ot include the findings of the investigation. Specifically, during a review of your film 's complaint, QuVa Complaint-0839 dated 12/28/2023, concerning the sterile finished diu g product, Hydi·omorphone HCL PF 30 mg (1 m g/ml) 30 ml in 0.9% Sodium Chl oride Solution P CA vial, ND C 7 00 92111779, Lot~ 6)(4) _j E xp i.J.y 12/20/2023 (Preparation Date 9/21/2023); and Lot[(6)(4) I Expi.J.y 11/1372023-CPreparation 8/15/2023). Your film 's customer repo1ie d the product fail ed internal testing and 6 total partially fill ed and 2 total fully fill ed unopened (3 paii ial and 1 fully filled samples from each lot) samples were returned to your QuVa Bloomsbmy , NJ location to undergo sample receiving insp ection, laborato1y testing us ing mass SQ ec troscopy, and investigation by QuVa Sugai· Lan d, TX . Your testing lab orato1y repo1ied L ot [(6)(4) I& LotJ~ 6l)(4) 11 samples tested positive.
Observation 3 — The responsibilities and procedures appli cabl e to the quality control unit
The responsibilities and procedures appli cabl e to the quality control unit are n ot fully followe d. Specifically, your fnm 's quality unit fail ed to adequately implement the procedure, COR-SOP-QS-0 01 2 fucident Repo1t ing and Escalation Failure to ade quately investigate. For ex ample: A. During a review of reported deviation, your firm fai led to adequately investigate and imp lement correction s to prevent the recurrence of the fo llowing: 1. Your firm documented the following DEV-0222 02222 dated 9/ 18/ 2023, y our firm reported OOS-00527 concerning a potency failure for Phenylephrine 20mg add to 250ml NS Bag, NOC/ Product Code 70092904205 , Lot ~(4) concerning laboratory resu lt s for the [( 15)(4 )1 sample of 204.1 % (Specification [ i:>)(4) I Your firm 's investigation reported the root cause as being compounding error. It was further reported the operator , II ... did not realize the bag wa s already dosed, and consequent.
Observation 4 — Your fnm failed to establish adequate written procedures for production and process
Your fnm failed to establish adequate written procedures for production and process controls design ed to assure that the diu g products have the identity, strength, purity, and quality that they are purported or represented to possess. Specifically, during a review of your fnm 's customer complaints, your fnm received 15 complaints for leaking syringes, 10 ml in SWFI 4 X and 50 ml NS syringes for cracks along the syringe barre l. For example, a review o fre ceived customer complaints, QuVa Complaints-05 61 , 0642, 0656, 0691, 0698, AMENDMENT 1 EMPLOYEE(S) SI GNATURE DATE ISSUED SEE REVERSE Camerson E Moore, I nves t iga t or 1 0/28/2024 OF THIS PAGE c,,,,,,o,e -. ~~E.MCICl'e • X &.,_._ 11>»21:01 12: 1...111 FORM FDA ~83 (09/ 08) PREVIOUS EDmON OBSOLEJE INS PEC TIONAL OB SERVATIONS PAGE 6 of? PAGES
What a Form 483 means
A Form FDA 483 is issued at the close of an FDA facility inspection to list conditions an investigator observed that may violate the Federal Food, Drug, and Cosmetic Act or its implementing regulations. It reflects the investigator's professional judgment at that point in time and is not a final agency determination, an enforcement action, or proof that a violation occurred. Firms are expected to respond in writing, typically within 15 business days, describing the corrective and preventive actions they plan to take. FDA reviews that response, along with any follow-up evidence, before deciding what happens next. Many 483s are resolved through corrective action alone. When FDA judges a firm's response inadequate, or when the underlying conditions are serious enough, the observations documented here can lead to a Warning Letter or further regulatory action. This page presents the observations exactly as recorded on the FDA-issued document; always confirm citation language against the original record before relying on it.
QuVa Pharma Inc’s FDA history
Argus HQ has recorded 3 total FDA actions tied to QuVa Pharma Inc: 0 warning letters, 0 recalls, 0 approval records, and 3 Form 483 inspection citations.
Frequently asked questions
- What is an FDA Form 483?
- A Form FDA 483 lists an FDA investigator's written observations at the close of a facility inspection, issued under section 704(b) of the Federal Food, Drug, and Cosmetic Act. It documents conditions the investigator judged may violate FDA regulations. A 483 is not an enforcement action or a final determination that a violation occurred.
- Does this Form 483 mean QuVa Pharma Inc violated the law?
- No. A Form 483 documents an investigator's observations only. FDA reviews the firm's written response and any corrective actions taken before deciding whether further action is warranted, and many 483s are closed without additional enforcement once a firm shows adequate correction.
- What happens after a Form 483 is issued?
- The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.
- Has QuVa Pharma Inc had other FDA inspection citations?
- Yes. Argus HQ has recorded 3 total FDA actions tied to QuVa Pharma Inc, including 3 Form 483 inspection citations.
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Related enforcement actions
Full FDA history for QuVa Pharma IncCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2024). Form 483 Record: QuVa Pharma Inc, October 28, 2024 — 4 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-quva-pharma-inc-2024-10-28-3012053582
"Form 483 Record: QuVa Pharma Inc, October 28, 2024 — 4 Citations." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/483/fda-483-quva-pharma-inc-2024-10-28-3012053582.
Argus HQ Research. "Form 483 Record: QuVa Pharma Inc, October 28, 2024 — 4 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-quva-pharma-inc-2024-10-28-3012053582.
@misc{argushq_argushq_ai_483_fda_483_quva_pharma_inc_2024_10_28_3012053582_2024,
title = {Form 483 Record: QuVa Pharma Inc, October 28, 2024 — 4 Citations},
author = {{Argus HQ Research}},
year = {2024},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-quva-pharma-inc-2024-10-28-3012053582},
note = {Accessed: July 15, 2026}
}