New Era Pharmacy, LLC – FDA Inspection, Oct 4, 2016

Record Details

This FDA Inspection record concerns New Era Pharmacy, LLC, with an inspection on October 4, 2016, issued by the Seattle District Office, covering human drugs.

Company: New Era Pharmacy, LLC
Inspection Date: October 4, 2016
Product Type: Human Drugs
Office: Seattle District Office
People: Darren S. Brown (FDA Associated Person)
Jeffery A. Johnson (FDA Associated Person)

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ID · ae38f0f0-afaf-4338-b574-3d5631738c8e

Inspection Facts

Inspection number: 992276
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.113(b)Procedures for sterile drug products
21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
21 CFR 211.42(c)(10)(v)Cleaning System

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FDA Inspection

New Era Pharmacy, LLCOctober 4, 2016