FDA Intel

Eagle Pharmacy, Inc.

Form 483 issued August 12, 2021 · Hoover, Alabama

Inspection
Jul 26 – Aug 12, 2021
Investigators
Demario L. Walls· June P. Page· Susan O. Oladeji
Observations
6
Pages
5
FEI number
3011688532

In short: On August 12, 2021, FDA issued a Form 483 with 6 observations to Eagle Pharmacy, Inc. in Hoover, Alabama (FEI 3011688532) after an inspection that ran Jul 26 – Aug 12, 2021. The investigators were Demario L. Walls, June P. Page and Susan O. Oladeji. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).

At a glance

Facilities & equipment and production account for 4 of 6 observations.

Facilities & equipment2
Production2
Laboratory controls2

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.42(c)(10)(iv)

    Aseptic processing areas are deficient regarding the system…

  2. 02
    21 CFR 211.42(c)(10)(v)

    Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room…

  3. 03
    21 CFR 211.113(b)

    Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…

  4. 04
    21 CFR 211.160(b)

    Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…

2 more observations

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

Get the full 483

This inspection in context

The investigator

Demario L. Walls

18 documents · 2020–2026

Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.

The firm

Eagle Pharmacy, Inc. history

All 6 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.42(c)(10)(iv)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Eagle Pharmacy, Inc.?

FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.

Who inspected Eagle Pharmacy, Inc.?

Demario L. Walls, June P. Page and Susan O. Oladeji are named on this Form 483, for the inspection of Jul 26 – Aug 12, 2021. Each investigator has a profile showing what they cite most.

When was Eagle Pharmacy, Inc. inspected by FDA?

The inspection ran Jul 26 – Aug 12, 2021, and the Form 483 is dated August 12, 2021.

How do I get the full Form 483 for Eagle 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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