AcariaHealth Pharmacy, Inc.

Form 483 issued September 12, 2018 · Falls Church, Virginia

Inspection
Aug 27 – Sep 12, 2018
Investigator
Marcus A. Ray
Observations
3
Pages
1
FEI number
3001465817

In short: On September 12, 2018, FDA issued a Form 483 with 3 observations to AcariaHealth Pharmacy, Inc. in Falls Church, Virginia (FEI 3001465817) after an inspection that ran Aug 27 – Sep 12, 2018. The investigator was Marcus A. Ray. Most observations concern facilities & equipment and materials.

At a glance

2 of 3 observations on this 483 concern facilities & equipment.

Facilities & equipment2
Materials1

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01

    Non-microbial contamination was observed…

  2. 02

    The use of sporicidal agents in the cleanrooms and/or ISO 5 area…

  3. 03

    You used a non-pharmaceutical grade component in the formulation…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

Questions about this 483

What did FDA find at AcariaHealth Pharmacy, Inc.?

FDA listed 3 observations on this Form 483, mostly about facilities & equipment and materials. The opening words of each observation are shown on this page.

Who inspected AcariaHealth Pharmacy, Inc.?

Marcus A. Ray is named on this Form 483, for the inspection of Aug 27 – Sep 12, 2018. Each investigator has a profile showing what they cite most.

When was AcariaHealth Pharmacy, Inc. inspected by FDA?

The inspection ran Aug 27 – Sep 12, 2018, and the Form 483 is dated September 12, 2018.

How do I get the full Form 483 for AcariaHealth Pharmacy, Inc.?

Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.

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