Form FDA 483 · Issued 2026-04-09
Wells Pharmacy Inc — FDA Form 483 Analysis
FEI: 3011761321 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Outsourcing Facility) · Lead Investigator: David K. Chen
FDA Form 483 issued to Wells Pharmacy Inc (FEI 3011761321) on 2026-04-09 following an inspection of its outsourcing facility operations in Tennessee. The report documents 4 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Cleaning Validation, Sanitation Logs & Pest Control.
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Observation-by-Observation 21 CFR Breakdown (4)
Observation #1 · 21 CFR 314.80(b)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
REPEAT CITATION AT FACILITY
Failure to develop written procedures
Inspector Observation Language: "Written procedures have not been developed for the [surveillance] [receipt] [evaluation] [reporting to FDA] of post marketing adverse drug experiences. Specifically, observed during inspection of Wells Pharmacy Inc on 2026-04-09."
Plain-English Meaning: Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Standard CAPA Remediation Path: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.
Observation #2 · 21 CFR 211.182
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Written records kept in individual logs
Inspector Observation Language: "Written records of major equipment [cleaning] [maintenance] [use] are not included in individual equipment logs. Specifically, observed during inspection of Wells Pharmacy Inc on 2026-04-09."
Plain-English Meaning: Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
Standard CAPA Remediation Path: Implement lot-linked equipment cleaning verification logs with QA sign-off before line clearance, ATP/allergen swabbing after shared-line runs, and weekly documented pest-control inspections.
Observation #3 · 21 CFR 211.125(a)
Label Control, Undeclared Allergens & Structure/Function Claims
FIRST-TIME OBSERVATION
Strict control not exercised over labeling issued
Inspector Observation Language: "Strict control is not exercised over labeling issued for use in drug product labeling operations. Specifically, observed during inspection of Wells Pharmacy Inc on 2026-04-09."
Plain-English Meaning: Undeclared major food allergens (milk, soy, wheat, tree nuts, peanuts, egg, sesame), label mix-ups at the packaging line, or unauthorized disease treatment claims.
Standard CAPA Remediation Path: Implement 100% barcode/vision verification on packaging lines, strict allergen matrix segregation, and regulatory review removing disease endpoints from supplement/cosmetic copy.
Observation #4 · 21 CFR 211.46(b)
Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems
FIRST-TIME OBSERVATION
Equipment for Environmental Control
Inspector Observation Language: "Equipment for adequate control over [air pressure] [micro-organisms] [dust] [humidity] [temperature] is not provided when appropriate for the manufacture, processing, packing or holding of a drug product. Specifically, observed during inspection of Wells Pharmacy Inc on 2026-04-09."
Plain-English Meaning: Scales, thermometers, pH meters, autoclaves, or purified water systems lacking current NIST-traceable calibration or process validation.
Standard CAPA Remediation Path: Tag all critical measuring instruments with calibration due dates, lock out overdue devices, and perform weekly TOC/conductivity/bioburden testing on purified water loops.