Does this Form 483 mean Wells Pharmacy 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.

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 Wells Pharmacy Inc. had other FDA inspection citations?

Yes. Argus HQ has recorded 2 total FDA actions tied to Wells Pharmacy Inc., including 2 Form 483 inspection citations.

What is the FEI / inspection ID for this Form 483?

FEI / inspection ID: 3011761321.

FDA Form 483 — Wells Pharmacy Inc. (April 25, 2025)

Here's the summary: FDA inspected Wells Pharmacy Inc. in Tennessee and issued a Form 483 listing 1 inspectional observation following an inspection that concluded 2025-04-25. FDA records classify Wells Pharmacy 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	Wells Pharmacy Inc.
FEI / inspection ID	3011761321
Inspection end date	April 25, 2025
Citation count	1

Citations explained

Observation 1 — 1 n

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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.

Wells Pharmacy Inc’s FDA history

Argus HQ has recorded 2 total FDA actions tied to Wells Pharmacy Inc: 0 warning letters, 0 recalls, 0 approval records, and 2 Form 483 inspection citations.

Frequently asked questions

Does this Form 483 mean Wells Pharmacy 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.
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 Wells Pharmacy Inc. had other FDA inspection citations?: Yes. Argus HQ has recorded 2 total FDA actions tied to Wells Pharmacy Inc., including 2 Form 483 inspection citations.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3011761321.

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Full FDA history for Wells Pharmacy 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). FDA Form 483 — Wells Pharmacy Inc. (April 25, 2025) — 1 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-wells-pharmacy-inc-2025-04-25-3011761321

MLA

"FDA Form 483 — Wells Pharmacy Inc. (April 25, 2025) — 1 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-wells-pharmacy-inc-2025-04-25-3011761321.

Chicago

Argus HQ Research. "FDA Form 483 — Wells Pharmacy Inc. (April 25, 2025) — 1 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-wells-pharmacy-inc-2025-04-25-3011761321.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_wells_pharmacy_inc_2025_04_25_3011761321_2025,
  title = {FDA Form 483 — Wells Pharmacy Inc. (April 25, 2025) — 1 Citations},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-wells-pharmacy-inc-2025-04-25-3011761321},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗