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 Palmetto Isotopes LLC 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 — Palmetto Isotopes LLC (February 28, 2025)

FDA inspected Palmetto Isotopes LLC in South Carolina and issued a Form 483 listing 1 inspectional observation following an inspection that concluded 2025-02-28. FDA records classify Palmetto Isotopes LLC as a nuclear pharmacy. 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	Palmetto Isotopes LLC
FEI / inspection ID	3016492204
Inspection end date	February 28, 2025
Citation count	1

Citations explained

Observation 1 — Smoke studies were not perfo1med under dynamic conditions

Smoke studies were not perfo1med under dynamic conditions. Specifically, EMPLO YEE(S) SI GNATURE DATE ISSUED SEE REVERSE Tai ch un Qi n , I n ve s t i ga t o r 2/28/202 5 OF THIS PAGE T.....,a,, ~~~~i~~.X = n FORM FDA ~83 ( 09/08) PREVIOUS EDmON OBSOLEJE INS PEC TIONAL OB SERVATIONS PAGE 2 of5 PAGES

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.

Palmetto Isotopes LLC’s FDA history

Argus HQ has recorded 1 total FDA action tied to Palmetto Isotopes LLC: 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 Palmetto Isotopes LLC 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 Palmetto Isotopes LLC

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 Form 483 — Palmetto Isotopes LLC (February 28, 2025) — 1 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-palmetto-isotopes-llc-2025-02-28-3016492204

MLA

"FDA Form 483 — Palmetto Isotopes LLC (February 28, 2025) — 1 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-palmetto-isotopes-llc-2025-02-28-3016492204.

Chicago

Argus HQ Research. "FDA Form 483 — Palmetto Isotopes LLC (February 28, 2025) — 1 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-palmetto-isotopes-llc-2025-02-28-3016492204.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_palmetto_isotopes_llc_2025_02_28_3016492204_2025,
  title = {FDA Form 483 — Palmetto Isotopes LLC (February 28, 2025) — 1 Citations},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-palmetto-isotopes-llc-2025-02-28-3016492204},
  note = {Accessed: July 15, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗