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Wells Pharmacy, Inc FDA Inspection Record

FEI 3011761321 · Inspections, Form 483s, warning letters and import refusals

Wells Pharmacy, Inc is an FDA-registered facility (FEI 3011761321) located in Dyersburg, TN, US. Registered operations: REPACK. RegDataLab tracks 4 FDA inspections at this facility.

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What FDA found at this site

Latest inspection: Apr 25, 2025: Voluntary Action Indicated (VAI)
Inspections on record: 4 (1 OAI, 3 VAI)
Last OAI inspection: Oct 20, 2016
Warning letters: None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Form 483 and inspection documents: 9 in FDA's reading room
Recalls as the recalling firm: 1, latest Sep 19, 2016

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

Date	Result	What FDA cited
Apr 25, 2025	Voluntary Action Indicated (VAI)	Protection from external factors (21 CFR 211.94(b)) Controlled release dosage form testing (21 CFR 211.167(c)) Drug product labels, fails to include (FDCA 503B(a)(10)(A)) Scientifically sound laboratory controls (21 CFR 211.160(b))
Jan 28, 2021	Voluntary Action Indicated (VAI)	Approve or reject procedures or specs (21 CFR 211.22(c)) Supervisor Training/Education/Experience (21 CFR 211.25(b)) Buildings of Suitable Size, Construction, Location (21 CFR 211.42(a)) Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) and 2 more
Apr 27, 2018	Voluntary Action Indicated (VAI)	Approve or reject procedures or specs (21 CFR 211.22(c)) Buildings of Suitable Size, Construction, Location (21 CFR 211.42(a)) Product flow through building is inadequate (21 CFR 211.42(b)) Computer control of master formula records (21 CFR 211.68(b)) and 9 more
Oct 20, 2016	Official Action Indicated (OAI)	No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

Date	Class	Recall	Product and reason
Sep 19, 2016	Class II	D-0126-2017	Testosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Network and 6 more products Superpotent and Subpotent drugs

Form 483s and inspection documents

483 on FDA.gov
Inspection Apr 6, 2026 to Apr 9, 2026 (dates printed on the document). FDA listing date Apr 9, 2026. Published by FDA May 8, 2026.
Untitled Letter on FDA.gov
FDA listing date Oct 14, 2025, which is not always the inspection or issue date. Published by FDA Dec 18, 2025.
483 on FDA.gov
FDA listing date Apr 25, 2025, which is not always the inspection or issue date. Published by FDA Aug 7, 2025.
Untitled Letter on FDA.gov
FDA listing date May 22, 2022, which is not always the inspection or issue date. Published by FDA Nov 21, 2022.
483 on FDA.gov
Issued Jan 28, 2021 (dates printed on the document). FDA listing date Jan 28, 2021. Published by FDA Mar 31, 2021.
FMD-145 Letter on FDA.gov
FDA listing date Aug 6, 2020, which is not always the inspection or issue date. Published by FDA Sep 1, 2020.
FMD-145 Letter on FDA.gov
FDA listing date Apr 15, 2020, which is not always the inspection or issue date. Published by FDA May 4, 2020.
483 on FDA.gov
Inspection Apr 16, 2018 to Apr 27, 2018, issued Apr 27, 2018 (dates printed on the document). FDA listing date Oct 24, 2018. Published by FDA Jan 18, 2024.
483 on FDA.gov
FDA listing date Apr 12, 2017, which is not always the inspection or issue date. Published by FDA Jan 18, 2024.

Facility details

Company: Wells Pharmacy, Inc
Location: Dyersburg, TN (US)
Registration Expires: Dec 31, 2027
Operations: REPACK
Source: decrs