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 Overton Brooks VA Medical Center 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 — Overton Brooks VA Medical Center (December 18, 2024)

At a glance: FDA inspected Overton Brooks VA Medical Center in Louisiana and issued a Form 483 listing 3 inspectional observations following an inspection that concluded 2024-12-18. FDA records classify Overton Brooks VA Medical Center as a producer of sterile and non sterile drug products. 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.

Key facts

Firm	Overton Brooks VA Medical Center
FEI / inspection ID	3013236711
Inspection end date	December 18, 2024
Citation count	3

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 — Hazardous mugs were produced without providing ad equate containmen t, segregation, and/or

Hazardous mugs were produced without providing ad equate containmen t, segregation, and/or cleaning of work s urfaces, utensils, and/or personnel to prevent cross-contamination. Specifically, During production of Fluorouracil 5 0mg/ml in your fnm 's hazardous clean room on 12/ 11 /2024, your fnm 's phaima cist inadvertently threw away the diug product from the ISO-5 hood prior to adding the total am ount needed to the finish ed product. Your pha1macist retrieved the dmg product fr om the hazai·dous waste bin located un de r the ISO-5 hood, wiped the vial with sterile 4 (b H l , then proceeded to use the product to fi nish producing. This hazardous waste bin was approximately 314th full of various hazai·dous products when the pha1macist retrieved the Fluorouracil. Your pha1macist was on their way to put the finished product in the pass through fo r use when I stopped them to ask what they planned to do with the product. Your pha1macist.

Observation 2 — Personnel infrequently changed and sanitized gloves to prevent contamination

Personnel infrequently changed and sanitized gloves to prevent contamination. Specifically, EMPLOYE E($) SIGNATURE DATE lSSUEO SEE REVERSE Lo gan T Williams, Investigat o r 1 2/ 18 /2024 OF THIS PAGE t.ogan T ~bn6 20029SS05S ~ :12-18-202,I X 14'21~

Observation 3 — Failure to conduct media fills that closely simulate aseptic production operations un

Failure to conduct media fills that closely simulate aseptic production operations un de r the worst-case, most-challenging, and stressful conditions. Speci fi ca lly, Media fills ai·e perfo 1med filling [(o) -(4) I) media into vials. Your fnm does not produce any products in vials. The most collllllon final packaging is IV Bag fo ll owed by syringe. Your fnm's cmTent media fill protocol requires operators to per fo1m p >) (4 )Jsets of l b) (.ifl transfers into a final vial container. During production of on 12/11/24, I observed up to ten or more transfers. r(I>) (lJY vials were reconstituted and then each vial's contents were filled into an IV bag during production of en fo rtumab vedotin-ejfv l 0mg/ml in the chemo buffer room. *DATES OF INSPECTION 12/1 0/2024(Tue), 12/l l/2024(Wed), 12/ 12/2024(Thu), 12/ 13 /2024(Fri), 12/16/2024(Mon), 12/1 7/2024(Tue), 12/18/2024(Wed) SEE REVERSE OF THIS PAGE EMPLOYE E($) SIGNATURE Log a n T Wi ll iams , I n.

Overton Brooks VA Medical Center’s FDA history

Argus HQ has recorded 1 total FDA action tied to Overton Brooks VA Medical Center: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

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 Overton Brooks VA Medical Center 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 Overton Brooks VA Medical Center

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 (2024). FDA Form 483 — Overton Brooks VA Medical Center (December 18, 2024) — 3 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-overton-brooks-va-medical-center-2024-12-18-3013236711

MLA

"FDA Form 483 — Overton Brooks VA Medical Center (December 18, 2024) — 3 Citations." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/483/fda-483-overton-brooks-va-medical-center-2024-12-18-3013236711.

Chicago

Argus HQ Research. "FDA Form 483 — Overton Brooks VA Medical Center (December 18, 2024) — 3 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-overton-brooks-va-medical-center-2024-12-18-3013236711.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_overton_brooks_va_medical_center_2024_12_18_3013236711_2024,
  title = {FDA Form 483 — Overton Brooks VA Medical Center (December 18, 2024) — 3 Citations},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-overton-brooks-va-medical-center-2024-12-18-3013236711},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗