Peoples Pharmacy, Inc.

Form 483 issued July 28, 2014 · Austin, Texas

Inspection
Jul 14 – Jul 28, 2014
Investigator
Margaret M. Annes
Observations
2
Pages
1
FEI number
3005331940

In short: On July 28, 2014, FDA issued a Form 483 with 2 observations to Peoples Pharmacy, Inc. in Austin, Texas (FEI 3005331940) after an inspection that ran Jul 14 – Jul 28, 2014. The investigator was Margaret M. Annes. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.166 (stability testing).

At a glance

2 of 2 observations on this 483 concern laboratory controls.

Laboratory controls2

Most cited: 21 CFR 211.166(a) (1×) · 211.165(a) (1×)

What FDA observed

Preview: the opening words of each observation
  1. 01

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

  2. 02

    Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…

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 Peoples Pharmacy, Inc.?

FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.

Who inspected Peoples Pharmacy, Inc.?

Margaret M. Annes is named on this Form 483, for the inspection of Jul 14 – Jul 28, 2014. Each investigator has a profile showing what they cite most.

When was Peoples Pharmacy, Inc. inspected by FDA?

The inspection ran Jul 14 – Jul 28, 2014, and the Form 483 is dated July 28, 2014.

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

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