Peoples Pharmacy, Inc.

Form 483 issued November 28, 2017 · Austin, Texas

Inspection
Nov 28, 2017
Investigator
Margaret M. Annes
Observations
2
Pages
2
FEI number
3005331940

In short: On November 28, 2017, FDA issued a Form 483 with 2 observations to Peoples Pharmacy, Inc. in Austin, Texas (FEI 3005331940) after an inspection that ran Nov 28, 2017. The investigator was Margaret M. Annes. Most observations concern materials and facilities & equipment; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).

At a glance

Materials and facilities & equipment account for 2 of 2 observations.

Materials1
Facilities & equipment1

Most cited: 21 CFR 211.84 (1×) · 211.67 (1×)

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-pharmaceutical grade components are used in the…

  2. 02

    Hazardous or highly potent drugs were produced without providing adequate contairunent, segregation and/or cleaning ofwork surfaces…

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 materials and facilities & equipment. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). 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 Nov 28, 2017. Each investigator has a profile showing what they cite most.

When was Peoples Pharmacy, Inc. inspected by FDA?

The inspection ran Nov 28, 2017, and the Form 483 is dated November 28, 2017.

How do I get the full Form 483 for Peoples 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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