Eagle Pharmacy, Inc.
Form 483 issued August 3, 2020 · Hoover, Alabama
- Inspection
- Aug 3, 2020
- Investigator
- Samantha J. Bradley
- Observations
- 10
- Pages
- 7
- FEI number
- 3011688532
In short: On August 3, 2020, FDA issued a Form 483 with 10 observations to Eagle Pharmacy, Inc. in Hoover, Alabama (FEI 3011688532) after an inspection that ran Aug 3, 2020. The investigator was Samantha J. Bradley. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 04
Protective apparel is not worn as necessary to protect…
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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eagle Pharmacy, Inc.?
FDA listed 10 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.?
Samantha J. Bradley is named on this Form 483, for the inspection of Aug 3, 2020. Each investigator has a profile showing what they cite most.
When was Eagle Pharmacy, Inc. inspected by FDA?
The inspection ran Aug 3, 2020, and the Form 483 is dated August 3, 2020.
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.