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 Inspects QuVa Pharma, Inc.: Form 483 with 4 Citations (March 4, 2025)

Key facts

Firm	QuVa Pharma, Inc.
FEI / inspection ID	3013931875
Inspection end date	March 4, 2025
Citation count	4

Key takeaway: FDA inspected QuVa Pharma, Inc. in New Jersey and issued a Form 483 listing 4 inspectional observations following an inspection that concluded 2025-03-04. 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.

Citations explained

Observation 1 — The accmacy, specificity and reproducibility of test methods have not been established

The accmacy, specificity and reproducibility of test methods have not been established. Specifically, Yom finn did not appropriately quali fy the per fo nnance qualification, RDIReport-0083, for [(o) (4 ) I sterility testing method fo r Cefazolin 3g in l00mL Nonnal Saline (NS). Your firm did not achieve the percent recove1y !(b) (4 ) I) of all challenge microor ganisms, specifically P. aeruginosa. There is a non- confo1mance associated with the perfonnance qualification that states that low recove1y was achieved for P. aeruginosa so retesting was per fo1med and that all 3 replicates pass. The raw data sheets show that the method suitability testing was retested multiple times with only the results meeting criteria being reported. The initial test shows results of 33%, 0%, and 0% recove1y. The first retest shows results of 54%, 31%, and 62%. The second retest shows results of 30%, 60%, and an unrepo1ted result. The finn has used this method to test fo r sterility.

Observation 2 — Written procedures fo r sanitation are not followed

Written procedures fo r sanitation are not followed. Specifically, Your fnm did not perfonn 4 (b) < 1 cleaning in controlled non-classified fonnulation areas as required by procedure NJ-SO P- SA-0003, "Cleaning/Disinfection of Compounding Manufacturing Area s" . Your fnm' s cleaning log for Building 2, Room 1408 used for fo1mulation of bulk diug product for fmther processing does not include (6) (4)cleaning documentation until the week of 3/24/2025. Your fnm only documented a ~b) (4 )1 clean of this room. In addition, co nditions of the room were found to be in disrepair including build up of debris in the floor scale , apparent residue splashes on the ceiling and discoloration from potential dust build up on the air retmn grate that is located above where weighing and mixing occurs. This room is constructed with a di·op tile ceiling that does not lend itself to be easily

Observation 3 — The statistical quality control criteria fail to include appropriate rejection levels

The statistical quality control criteria fail to include appropriate rejection levels. Specifically, Your furn has a to) 4 < 1 overall reject limit for defects found in the visual inspection process that is not scientifically or statistically justified. Individual defect categories do not have reject limits. Your fnm does not open deviations or events until the {b) l'l Yreject rate is reached. During production of Cefazolin Sodium PF 2mg, 20mL in SWFI syringe, l ot b (4 your visual inspection process rejected 9.6% of 4 (b) 4 ( ) syringes including (bH \ejects for liquid past the plunger. These liquid past the plunger units are major defects, as defined by procedure NJ-SOP-QA-0011 , "Performing Acceptable Quality Limit Inspections". The defect rate was not investigated or co ITe cted to prevent these defects from occmTing 41 during compounding. Your fnm has opened thirteen deviations for reject rates exceeding limits lbl< % of the batch) since I 0/ 14/2022. Since 11 /7/2024,.

Observation 4 — Employees engaged in the manufacture, processing and packing of a dmg product

Employees engaged in the manufacture, processing and packing of a dmg product lack the training required to perfo1m their assigned functions. Specifically, A) Your fnm 's syringe visual inspection qualification kit used during visual inspection qualification testing is not representative of the visual inspection process. The qualification kits used contain a Inix of syrinoe sizes ran8l:1g from ~bH4 to lb) .PflL. The 41 '(.bf< unit kits contain a Inix of (6) (4) selected critical1 D 4) D (4 I selected major defects, and D 4 defects. This results in a test kit reject rate of a proximately (b) 4 4 < l. In addition, !bl ( l of the ~n◄i minor defects in the kit contain the same defect fo r (6) (4) B) Your firm 's qualification testing for visual inspection does not adequately simulate fatigue. The 11>H•l unit kit must be completed within (6) (4) and is repeated in 6 (4 fo r initial qualification. The operators routinely.

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

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 (2025). FDA Inspects QuVa Pharma, Inc.: Form 483 with 4 Citations (March 4, 2025). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-quva-pharma-inc-2025-03-04-3013931875

MLA

"FDA Inspects QuVa Pharma, Inc.: Form 483 with 4 Citations (March 4, 2025)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-quva-pharma-inc-2025-03-04-3013931875.

Chicago

Argus HQ Research. "FDA Inspects QuVa Pharma, Inc.: Form 483 with 4 Citations (March 4, 2025)." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-quva-pharma-inc-2025-03-04-3013931875.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_quva_pharma_inc_2025_03_04_3013931875_2025,
  title = {FDA Inspects QuVa Pharma, Inc.: Form 483 with 4 Citations (March 4, 2025)},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-quva-pharma-inc-2025-03-04-3013931875},
  note = {Accessed: July 15, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗