Jungle Jim's Pharmacy

Form 483 issued January 26, 2015 · Fairfield, Ohio

Inspection
Jan 12 – Jan 26, 2015
Investigator
Joshua P. Wireman
Observations
3
Pages
3
FEI number
3011299928

In short: On January 26, 2015, FDA issued a Form 483 with 3 observations to Jungle Jim's Pharmacy in Fairfield, Ohio (FEI 3011299928) after an inspection that ran Jan 12 – Jan 26, 2015. The investigator was Joshua P. Wireman. Most observations concern production and laboratory controls.

At a glance

Production and laboratory controls account for 2 of 3 observations.

Production1
Laboratory controls1
Facilities & equipment1

What FDA observed

Preview: the opening words of each observation

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

  1. 01

    Observation 1: scanned text, readable in the full document.

  2. 02

    There is no written testing program designed to assess the stability…

  3. 03

    Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…

The full 483

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

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This inspection in context

Questions about this 483

What did FDA find at Jungle Jim's Pharmacy?

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

Who inspected Jungle Jim's Pharmacy?

Joshua P. Wireman is named on this Form 483, for the inspection of Jan 12 – Jan 26, 2015. Each investigator has a profile showing what they cite most.

When was Jungle Jim's Pharmacy inspected by FDA?

The inspection ran Jan 12 – Jan 26, 2015, and the Form 483 is dated January 26, 2015.

How do I get the full Form 483 for Jungle Jim's Pharmacy?

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