Wells Pharmacy, Inc – FDA Inspection, Apr 27, 2018

Record Details

This FDA Inspection record concerns Wells Pharmacy, Inc, with an inspection on April 27, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Wells Pharmacy, Inc
Inspection Date: April 27, 2018
Product Type: Drugs
Office: Center for Drug Evaluation and Research
People: June P. Page (FDA Associated Person)
Pallavi K. Lele

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ID · 34f01f0d-9c5a-4237-8f40-03245e06b1ba

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1050115
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.68(b)Computer control of master formula records
21 CFR 211.42(c)(10)(v)Cleaning System
21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
21 CFR 211.192Quality control unit review of records
21 CFR 211.160(b)(4)Establishment of calibration procedures
21 CFR 211.198(a)Procedures to be written and followed
21 CFR 211.113(b)Validation lacking for sterile drug products
21 CFR 211.42(b)Product flow through building is inadequate
21 CFR 211.110(a)(3)Mixing adequacy

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Other FDA inspections of Wells Pharmacy, Inc

Date	Classification	Office	Project area
April 9, 2026	Not classified	New Orleans District Office	Drug Quality Assurance
April 25, 2025	VAI	New Orleans District Office	Drug Quality Assurance
January 28, 2021	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance
October 20, 2016	OAI	Center for Drug Evaluation and Research	Drug Quality Assurance