Department of the Army Blanchfield Army Community Hospital

Form 483 issued May 1, 2025

Inspection
May 1, 2025
Investigator
Cody D. Rickman
Observations
2
Pages
3
FEI number
1045250

In short: On May 1, 2025, FDA issued a Form 483 with 2 observations to Department of the Army Blanchfield Army Community Hospital (FEI 1045250) after an inspection that ran May 1, 2025. The investigator was Cody D. Rickman. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.160 (records).

At a glance

Observations span 1 system, led by biologics cgmp.

Biologics CGMP1
Other1

Most cited: 21 CFR 606.160 (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

    Failure to perform a thorough investigation…

  2. 02

    Records are not concurrently maintained with the performance of each significant step in the storage of…

The full 483

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

Get the full 483

This inspection in context

Questions about this 483

What did FDA find at Department of the Army Blanchfield Army Community Hospital?

FDA listed 2 observations on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.160 (records). The opening words of each observation are shown on this page.

Who inspected Department of the Army Blanchfield Army Community Hospital?

Cody D. Rickman is named on this Form 483, for the inspection of May 1, 2025. Each investigator has a profile showing what they cite most.

When was Department of the Army Blanchfield Army Community Hospital inspected by FDA?

The inspection ran May 1, 2025, and the Form 483 is dated May 1, 2025.

How do I get the full Form 483 for Department of the Army Blanchfield Army Community Hospital?

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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