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 Richmond 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.

Has Richmond VA Medical Center had other FDA inspection citations?

This is the only FDA action Argus HQ has on file for Richmond VA Medical Center so far. Argus ingests new FDA records daily.

FDA Form 483 — Richmond VA Medical Center (May 12, 2026)

Key facts

Firm	Richmond VA Medical Center
FEI / inspection ID	1174302
Inspection end date	May 12, 2026
Citation count	2

In short: FDA inspected Richmond VA Medical Center in Virginia and issued a Form 483 listing 2 inspectional observations following an inspection that concluded 2026-05-12. FDA records classify Richmond VA Medical Center as a producer of 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.

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 — Personnel were observed m oving quickly in a critical area or in

Personnel were observed m oving quickly in a critical area or in an area immediately adjacent to a critical area likely causing dismption of unidirectional airflow. Specifically, On 05/05/2026, compounding technician was obse1ved preparing the fo llowing prescriptions in Buffer Room l H- ll0A: • RX n~6J c5>, Ct>) C7 XC~ - Remicade (Infliximab) 500mg/0.9%NS, 250mL IV bag The compounding technician was obse1ved moving quickly within the ISO 5 LAFW workspace dming aseptic manipulations, disrnpting unidirectional airflow and increasing the 1isk of introducing lesser-quality air into the ISO 5 critical area.

Observation 2 — Use of a dis infect ant in a manner insufficient to achieve

Use of a dis infect ant in a manner insufficient to achieve adequate levels of disinfection. Specifically, On 5/6/2026 dming [( 0)(4l cleaning operations, cleaning perfo1med within the ISO 5 classified laminar airflow hood (LAFH), cleaning procedmes were fo und to be inadequate in the following respects: a. A compounding technician was observed wiping the interior smfaces of the ISO 5 LAFH without using overlapping wipe passes dming the cleaning procedme. The absence of overlapping strokes resulted in visible gaps in smface contact, with some interior smface areas visibly not contacted or wetted by the disinfectant wip e. b. The compounding technician was obse1ved using a back-and- fo rth scrnbbing motion while wiping the inte1ior smfaces of the ISO 5 classified LAFH, rather than the required unid irectional wiping EMPLOYEE(S) SI GNATURE DATE ISSUED SEE REVERSE Tekalign Wondimu , I nves ti ga t or 5/ 1 2/2026 OF THIS PAGE Michael O Id owu, I nves ti ga t.

Richmond VA Medical Center’s FDA history

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

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 Richmond 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.
Has Richmond VA Medical Center had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for Richmond VA Medical Center so far. Argus ingests new FDA records daily.

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Full FDA history for Richmond 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 (2026). FDA Form 483 — Richmond VA Medical Center (May 12, 2026) — 2 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-richmond-va-medical-center-2026-05-12-1174302

MLA

"FDA Form 483 — Richmond VA Medical Center (May 12, 2026) — 2 Citations." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/483/fda-483-richmond-va-medical-center-2026-05-12-1174302.

Chicago

Argus HQ Research. "FDA Form 483 — Richmond VA Medical Center (May 12, 2026) — 2 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-richmond-va-medical-center-2026-05-12-1174302.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_richmond_va_medical_center_2026_05_12_1174302_2026,
  title = {FDA Form 483 — Richmond VA Medical Center (May 12, 2026) — 2 Citations},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-richmond-va-medical-center-2026-05-12-1174302},
  note = {Accessed: July 15, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗