Eagle Pharmacy, Inc.
Form 483 issued May 18, 2018 · Hoover, Alabama
- Inspection
- May 1 – May 18, 2018
- Investigator
- Samantha J. Bradley
- Observations
- 4
- Pages
- 3
- FEI number
- 3011688532
In short: On May 18, 2018, FDA issued a Form 483 with 4 observations to Eagle Pharmacy, Inc. in Hoover, Alabama (FEI 3011688532) after an inspection that ran May 1 – May 18, 2018. The investigator was Samantha J. Bradley. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Facilities & equipment and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 02
Appropriate procedures designed to prevent microbiological contamination of drug products purport ing to be sterile are…
- 03
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 04
Equipment ·and uten·silsare riot maintain·ed at appropriate intervals to prevent malfunctions that would alter the..safety; strength…
This inspection in context
Samantha J. Bradley
14 documents · 2013–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Alabama.
The firmEagle Pharmacy, Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eagle Pharmacy, Inc.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Eagle Pharmacy, Inc.?
Samantha J. Bradley is named on this Form 483, for the inspection of May 1 – May 18, 2018. Each investigator has a profile showing what they cite most.
When was Eagle Pharmacy, Inc. inspected by FDA?
The inspection ran May 1 – May 18, 2018, and the Form 483 is dated May 18, 2018.
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.