Farmville Discount Drug, Inc. DBA Best Value Drug – FDA Inspection, Nov 17, 2017

Record Details

This FDA Inspection record concerns Farmville Discount Drug, Inc. DBA Best Value Drug, with an inspection on November 17, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Farmville Discount Drug, Inc. DBA Best Value Drug
Inspection Date: November 17, 2017
Product Type: Drugs
Office: Center for Drug Evaluation and Research
People: Larry K. Hampton (Company Rep)
Rachael L. Derby (Issuing Officer)

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ID · c84583c8-e639-41bf-bf21-9600a0490f82

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 1031770
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued
Enforcement: Warning Letter

FDA Citations

FDCA 501(a)(2)(A)Disinfecting and cleaning agents, ISO 5 area
FDCA 501(a)(2)(A)Unsealed HEPA filter, perimeter
21 CFR 211.160(b)Scientifically sound laboratory controls
FDCA 501(a)(2)(A)First pass air blockage, open unit with sterile product
FDCA 501(a)(2)(A)Improper gowning, contamination
FDCA 501(a)(2)(A)Personnel contact outside ISO 5 area
21 CFR 211.113(b)Procedures for sterile drug products
FDCA 501(a)(2)(A)Air flow quality, higher classified area
FDCA 501(a)(2)(A)Flow of personnel and materials, facility

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FDA Inspection

Farmville Discount Drug, Inc. DBA Best Value DrugNovember 17, 2017