FDA-Inspected Site

Eagle Pharma Outsourcing LLC

4 FDA inspections are on record for Eagle Pharma Outsourcing LLC in Hoover, United States.

483· Form 483 issued

Hoover, United States · Last updated July 10, 2026

Overview

  • 4 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-02-27.

At a glance

Inspections

4

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
18 Feb 2025 – 27 Feb 2025Human Drugs483View 483 →
26 Jul 2021 – 12 Aug 2021Human Drugs483View 483 →
1 May 2018 – 18 May 2018Human Drugs483On file
3 Aug 2015 – 21 Aug 2015Human DrugsWLOn file

Observations on record

Form 483 observations cited at this site, most recent first.

27 Feb 2025
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Camerson E Moore

27 Feb 2025
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Camerson E Moore

27 Feb 2025
21 CFR 211.28(a)

Protective Apparel Not Worn

Cited by Camerson E Moore

27 Feb 2025
21 CFR 211.63

Equipment Design, Size and Location

Cited by Camerson E Moore

27 Feb 2025
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Camerson E Moore

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations2x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.28(a)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Eagle Pharma Outsourcing LLC's 4 Form 483s

Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat