Is a Form 483 the same as a Warning Letter?

No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.

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.

FDA Inspects Central Alabama Veterans Health Care System: Form 483 with 2 Citations (April 16, 2026)

Key facts

Firm	Central Alabama Veterans Health Care System
FEI / inspection ID	1073935
Inspection end date	April 16, 2026
Citation count	2

Key takeaway: FDA inspected Central Alabama Veterans Health Care System in Alabama and issued a Form 483 listing 2 inspectional observations following an inspection that concluded 2026-04-16. FDA records classify Central Alabama Veterans Health Care System 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.

Citations explained

Observation 1 — No measurement of room presstu·e differentials was observed during operations to demonstrate

No measurement of room presstu·e differentials was observed during operations to demonstrate proper airflow. 4 t cifically, yotu· fum does not adequately monitor differential presstu·e in the (6 ) (4 ) ...,..------- ISO 5 4 '(b) < I Ther < j standard configtu·ation has Minihelic gauges for the (15) (4) anclj(b) (4 ) 1at are not connected to an audible a am1 or alann mdicator light on the 6 4 control panel. Additionally, personnel do not doctunent differential pressm·e readings from either Minihelic gauge at leastr(b) 4< l on days o compollllding. CSPs I saw produced inside the 4 '(b) < I O Iron Sucrose 200 mg/Sodium Chloride 0.9% 100 mL CSP, barcode 73513V15, on 04/09/26 O Remicade (inflixllllab) 750 mg/Sodium Chloride 0.9% 250 mL CSP, barcode 719803357553V28, on 04/ 10/26 O Briumvi (ublituxllllab-xiiy) 450 mg/Soditun Chloride 0 .9 % 250 mL CSP, bru·code 719803356510V10, on 04/10/26

Observation 2 — Production areas have difficult to clean or contain porous, particle generating, or

Production areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces. Specifically, yotu· unclassified segregated compotmding area (SCA) established within the inpatient pharmacy contains smfaces that are not easily disinfected, impervious, free from drunage, or are particle generating. The SCA does not have specific physical boU11darie s but is defined as a( 6) 4) buffer zone arotu1d the 6 -(4r _____--.,_. ISO 5lti~ . The SCA contains a cracked drop ceiling tile which potentially allows the intrusion of air from t~ei:mm, an exposed sprinkler lleiid an air supply vent, an approximate I -inch ho le in the diywall, texttu·ed mineral fiber drop ceiling tiles, 4 [!bJ1 lsmall incubators, and ( 15) (4) oral solid dose cotmting machines. These smfaces could compromise the ISO 5 environment, pa1ticulru·ly when th~) 4< lctoor 1s opened during cleaning, maintenance, or compotu1ding activities. The SCA floor and ceiling are not included in thet6J (4} or (b) (4) cleaning and.

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.

Central Alabama Veterans Health Care System’s FDA history

Argus HQ has recorded 1 total FDA action tied to Central Alabama Veterans Health Care System: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 1073935.
Is a Form 483 the same as a Warning Letter?: No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.
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.

See if this 483 escalates to a warning letter — before your auditor asks.

Free weekly briefing tracks every FDA inspection outcome.

Full FDA history for Central Alabama Veterans Health Care System

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 Inspects Central Alabama Veterans Health Care System: Form 483 with 2 Citations (April 16, 2026). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-central-alabama-veterans-health-care-system-2026-04-16-1073935

MLA

"FDA Inspects Central Alabama Veterans Health Care System: Form 483 with 2 Citations (April 16, 2026)." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/483/fda-483-central-alabama-veterans-health-care-system-2026-04-16-1073935.

Chicago

Argus HQ Research. "FDA Inspects Central Alabama Veterans Health Care System: Form 483 with 2 Citations (April 16, 2026)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-central-alabama-veterans-health-care-system-2026-04-16-1073935.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_central_alabama_veterans_health_care_system_2026_04_16_1073935_2026,
  title = {FDA Inspects Central Alabama Veterans Health Care System: Form 483 with 2 Citations (April 16, 2026)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-central-alabama-veterans-health-care-system-2026-04-16-1073935},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗