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.

Does this Form 483 mean LeeSar, 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.

Form 483 Record: LeeSar, Inc., May 9, 2025

Here's the summary: FDA inspected LeeSar, Inc. in Florida and issued a Form 483 listing 1 inspectional observation following an inspection that concluded 2025-05-09. FDA records classify LeeSar, 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.

Key facts

Firm	LeeSar, Inc.
FEI / inspection ID	3010166880
Inspection end date	May 9, 2025
Citation count	1

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 — Yotu· fum failed to establish v.,ritten procedures for production and process controls

Yotu· fum failed to establish v.,ritten procedures for production and process controls designed to assure that the drug products have the identity, strength, pm-ity, and quality that they are ptupo,ted or represented to possess. Specifically, your fnm does no t have a change control program or written procedure to define and desc1ibe how your film will properly document and evaluate changes within your processes including but not limited to changes within your manufacturing operati ons, product spec ifications or standard operating procedures/programs. For example, on 08/19/ 2022 the fini shed pro?uct pH specifications for Azithromycin 500mg added to Dextrose 5% 2 50ml bag were changed from (o} (4) tq(6) {4)] but there is no change control documentation describing the justification and implementation of this change . *DATES OF INSPECTION 4/29/2025(Tue), 4/30/2025(Wed), 5/ 01 /2025(Thu), 5/02/2025(F,-i), 5/05/2025(Mon), 5/09/2025(F,-i) SEE REVERSE OF THIS PAG E EMPLOYEE($) SIGNATURE Kayla V Sprague, Investigator DATE lSSUEO 5/9/2025

LeeSar, Inc.’s FDA history

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

Frequently asked questions

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.
Does this Form 483 mean LeeSar, 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.

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Full FDA history for LeeSar, 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). Form 483 Record: LeeSar, Inc., May 9, 2025 — 1 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-leesar-inc-2025-05-09-3010166880

MLA

"Form 483 Record: LeeSar, Inc., May 9, 2025 — 1 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-leesar-inc-2025-05-09-3010166880.

Chicago

Argus HQ Research. "Form 483 Record: LeeSar, Inc., May 9, 2025 — 1 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-leesar-inc-2025-05-09-3010166880.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_leesar_inc_2025_05_09_3010166880_2025,
  title = {Form 483 Record: LeeSar, Inc., May 9, 2025 — 1 Citations},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-leesar-inc-2025-05-09-3010166880},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗