FDA Intel

C. B. Fleet Co

Form 483 issued April 18, 2025 · Lynchburg, Virginia

Inspection
Apr 14 – Apr 18, 2025
Investigators
David A. Oluwo· Homero W. Aguilar
Observations
4
Pages
8
FEI number
1111503

In short: On April 18, 2025, FDA issued a Form 483 with 4 observations to C. B. Fleet Co in Lynchburg, Virginia (FEI 1111503) after an inspection that ran Apr 14 – Apr 18, 2025. The investigators were David A. Oluwo and Homero W. Aguilar. Most observations concern quality system and laboratory controls.

At a glance

Quality system and laboratory controls account for 4 of 4 observations.

Quality system2
Laboratory controls2

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.192

    There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…

  2. 02
    21 CFR 211.160(b)

    Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…

  3. 03
    21 CFR 211.165(e)

    The specificity of test methods…

  4. 04
    21 CFR 211.22(d)

    The responsibilities and procedures applicable to the quality control unit are not in…

The full 483

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

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This inspection in context

The investigator

David A. Oluwo

27 documents · 2017–2026

Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Maryland.

The firm

C. B. Fleet Co history

All 3 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.192

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at C. B. Fleet Co?

FDA listed 4 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.

Who inspected C. B. Fleet Co?

David A. Oluwo and Homero W. Aguilar are named on this Form 483, for the inspection of Apr 14 – Apr 18, 2025. Each investigator has a profile showing what they cite most.

When was C. B. Fleet Co inspected by FDA?

The inspection ran Apr 14 – Apr 18, 2025, and the Form 483 is dated April 18, 2025.

How do I get the full Form 483 for C. B. Fleet Co?

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