Where can I read the full Form 483?

The verbatim inspection record is the source of truth — always confirm citation language against the original FDA document before acting.

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.

FDA Form 483 — QuVa Pharma Inc (May 4, 2026)

Key facts

Firm	QuVa Pharma Inc
FEI / inspection ID	3012053582
Inspection end date	May 4, 2026
Citation count	3

Key takeaway: FDA inspected QuVa Pharma Inc in Texas and issued a Form 483 listing 3 inspectional observations following an inspection that concluded 2026-05-04. FDA records classify QuVa Pharma Inc as a outsourcing facility. A Form 483 documents an investigator's findings at the close of an inspection under the Federal Food, Drug, and Cosmetic Act; it is not a final agency compliance determination. The observations on this page are drawn directly from the FDA-issued Form 483 record.

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.

Citations explained

Observation 1 — Procedures designed to prevent microbiological contamination of mug products pmp o1ting to

Procedures designed to prevent microbiological contamination of mug products pmp o1ting to be sterile are not established, written and followed. Specifically, your fnm fail ed to adequately establish procedures to prevent microbiological contamination of m11g products pmpo1ting to be sterile. For example, A. Your fnm fail ed to adequately define and document the frequency of disinfection of a device used by technicians to pick items off the floor and place items into the trash in the ISO 7 cleamooms. The device storage location has not been defined and documented. Cunently, your technicians hang the device on the side of the [(6) (4) Iu sed to hold mug components, utensils, m11g product containers, and finis hed m11g products. B. On 4/20/2026, during a site walk-through of your fnm 's ISO 7 class ified aseptic processing cleamoom, I observed a " black residue" near the ((6) (4)1 of eachj{.6) {.2J) used to ,Jhold mug components, utensils, m11g product containers, and finis hed.

Observation 2 — There is a failure to thoroughly r evi ew any unexplained discrepancy

There is a failure to thoroughly r evi ew any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been ah-eady distributed. Specifically, during a review of nonconfo nn ance number, IR-12512 (DEV-02984) documented on 14 Nov 2024, prior to compounding Fentanyl Citrate PF 50 mcg/mL Syringe, PC 700092168448, Lot 10138352, Expiiy 02/12/2025 compounding in ISO 7 Cleanroom Suite 7, ISO 5 LAFH numbed 6 4 ) ( ) your compounding technician found on the ISO 5 LAFH grate in front of the installed HEPA filter, a brown to black foreign residue contaminate, later within an investigation identifi ed as a "Heat Resistant 6 Sealant~ ) ri- ~11 • The sealant is applied during the HEPA filter production as an exterior coating. Potential paiiiculates from the degradation may become an a irborne contaminate a ffecting first au· quality us ed during aseptic processing of.

Observation 3 — Buildings u sed in the manufacturing, processing, packing and holding of a

Buildings u sed in the manufacturing, processing, packing and holding of a <lI11g product are n ot maintained in a good state of repair. Specifically, on 4/ 20/2026, during a site walk-through of your film's ISO classifi ed cleanroom, I observed paint peeling o ff Suite 3 ISO 8 Degowning Room wall comers and around the door frame EM PLOYE E($) SIG NATURE DATE lSSUEO SEE REVERSE Camer s o n E Moo r e , Investig a t o r -- 5 /4/2026 OF THIS PAGE ~E MOOre: ~ e.,. ~E.tr,txwe:• X Clele: ~ ~ 333 n :s6:u

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

Where can I read the full Form 483?: The verbatim inspection record is the source of truth — always confirm citation language against the original FDA document before acting.
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.

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Full FDA history for QuVa Pharma Inc

Compiled 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.

APA

Argus HQ Research (2026). FDA Form 483 — QuVa Pharma Inc (May 4, 2026) — 3 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-quva-pharma-inc-2026-05-04-3012053582

MLA

"FDA Form 483 — QuVa Pharma Inc (May 4, 2026) — 3 Citations." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/483/fda-483-quva-pharma-inc-2026-05-04-3012053582.

Chicago

Argus HQ Research. "FDA Form 483 — QuVa Pharma Inc (May 4, 2026) — 3 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-quva-pharma-inc-2026-05-04-3012053582.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_quva_pharma_inc_2026_05_04_3012053582_2026,
  title = {FDA Form 483 — QuVa Pharma Inc (May 4, 2026) — 3 Citations},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-quva-pharma-inc-2026-05-04-3012053582},
  note = {Accessed: July 15, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗