Key facts
| Firm | Wells Pharmacy Inc |
|---|---|
| FEI / inspection ID | 3011761321 |
| Inspection end date | April 9, 2026 |
| Citation count | 1 |
Citations explained
Observation 1 — Your fum failed to establish adequate written procedures for production and process
Your fum failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purpo1ted or represented to possess. Specifically, A) Inadequate Cleaning Validation Your cleaning validation (Disinfectant Efficacy Study) does not evaluate whether your cunent cleaning agents and procedures effectively remove hazardous drug products to prevent cross- contamination or product canyover. The cleaning agent manufacturer study provided as evidence for hazardous drng removal is inadequate for the following reasons: • It only evaluated Estradiol and Progesterone not all hazardous dmg products manufactlued at your facility. • It only tested >TT4 surfaces, not other product contact materials such as the plastic components of your fum's metal detector. [(6) (4) I • It is not representative of your cunent procedure. The study us1~d1 br~ l passes with the cleaning agent, but your cleaning procedure does not require a D) (4 ~ pass. EMPI.OYEE(S) SI GNATURE.
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.
See if this 483 escalates to a warning letter — before your auditor asks.
Free weekly briefing tracks every FDA inspection outcome.
Related enforcement actions
Full FDA history for Wells Pharmacy IncCompiled 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.
Argus HQ Research (2026). Wells Pharmacy Inc — FDA Form 483 Inspection, April 9, 2026 (1 Citations). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-wells-pharmacy-inc-2026-04-09-3011761321
"Wells Pharmacy Inc — FDA Form 483 Inspection, April 9, 2026 (1 Citations)." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/483/fda-483-wells-pharmacy-inc-2026-04-09-3011761321.
Argus HQ Research. "Wells Pharmacy Inc — FDA Form 483 Inspection, April 9, 2026 (1 Citations)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-wells-pharmacy-inc-2026-04-09-3011761321.
@misc{argushq_argushq_ai_483_fda_483_wells_pharmacy_inc_2026_04_09_3011761321_2026,
title = {Wells Pharmacy Inc — FDA Form 483 Inspection, April 9, 2026 (1 Citations)},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-wells-pharmacy-inc-2026-04-09-3011761321},
note = {Accessed: July 13, 2026}
}