Delta Labs of South Florida Corp

Form 483 issued July 8, 2025 · Medley, Florida

Inspection
Jun 27 – Jul 8, 2025
Investigator
Joanne E. King
Observations
2
Pages
4
FEI number
3021615345

In short: On July 8, 2025, FDA issued a Form 483 with 2 observations to Delta Labs of South Florida Corp in Medley, Florida (FEI 3021615345) after an inspection that ran Jun 27 – Jul 8, 2025. The investigator was Joanne E. King. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).

At a glance

2 of 2 observations on this 483 concern laboratory controls.

Laboratory controls2

Most cited: 21 CFR 211.194(a)(2) (1×) · 211.194(a) (1×)

What FDA observed

Preview: the opening words of each observation
  1. 01

    Verification of the suitability of the testing methods is deficient in that they are not performed…

  2. 02

    Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…

The full 483

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

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This inspection in context

Questions about this 483

What did FDA find at Delta Labs of South Florida Corp?

FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.

Who inspected Delta Labs of South Florida Corp?

Joanne E. King is named on this Form 483, for the inspection of Jun 27 – Jul 8, 2025. Each investigator has a profile showing what they cite most.

When was Delta Labs of South Florida Corp inspected by FDA?

The inspection ran Jun 27 – Jul 8, 2025, and the Form 483 is dated July 8, 2025.

How do I get the full Form 483 for Delta Labs of South Florida Corp?

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