FDA Intel

Dr. G. H. Tichenor’s Antiseptic Company

Form 483 issued May 17, 2024 · New Orleans, Louisiana

Inspection
May 13 – May 17, 2024
Investigator
Brittny C. Cargo
Observations
9
Pages
7
FEI number
2311409

In short: On May 17, 2024, FDA issued a Form 483 with 9 observations to Dr. G. H. Tichenor’s Antiseptic Company in New Orleans, Louisiana (FEI 2311409) after an inspection that ran May 13 – May 17, 2024. The investigator was Brittny C. Cargo. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).

At a glance

Observations span 4 systems, led by laboratory controls.

Laboratory controls3
Quality system2
Facilities & equipment2
Packaging & labeling1
Other1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 211.22(d)

    The responsibilities and procedures applicable to the quality control unit…

  2. 02
    21 CFR 211.137(a)

    Drug products do not bear an expiration date determined by appropriate stability data to assure they…

  3. 03
    21 CFR 211.165(a)

    Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…

  4. 04
    21 CFR 211.165(b)

    Each batch of drug product required to be free of objectionable microorganisms is not tested…

5 more observations

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

Get the full 483

This inspection in context

The investigator

Brittny C. Cargo

14 documents · 2022–2026

Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Louisiana.

The firm

Dr. G. H. Tichenor’s Antiseptic Company history

All 2 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.22(d)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Dr. G. H. Tichenor’s Antiseptic Company?

FDA listed 9 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.

Who inspected Dr. G. H. Tichenor’s Antiseptic Company?

Brittny C. Cargo is named on this Form 483, for the inspection of May 13 – May 17, 2024. Each investigator has a profile showing what they cite most.

When was Dr. G. H. Tichenor’s Antiseptic Company inspected by FDA?

The inspection ran May 13 – May 17, 2024, and the Form 483 is dated May 17, 2024.

How do I get the full Form 483 for Dr. G. H. Tichenor’s Antiseptic Company?

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