Frederick J. Raal, FCP(SA), PhD, MD

Form 483 issued September 4, 2025 · Johannesburg, South Africa

Inspection
Sep 1 – Sep 4, 2025
Investigator
Angelica M. Chica
Observations
1
Pages
3
FEI number
3009568404

In short: On September 4, 2025, FDA issued a Form 483 with 1 observation to Frederick J. Raal, FCP(SA), PhD, MD in Johannesburg, Gauteng (FEI 3009568404) after an inspection that ran Sep 1 – Sep 4, 2025. The investigator was Angelica M. Chica. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 312.62 (investigator recordkeeping and record retention).

At a glance

1 of 1 observations on this 483 concern clinical (bimo).

Clinical (BIMO)1

Most cited: 21 CFR 312.62(b) (1×)

What FDA observed

Preview: the opening words of each observation
  1. 01

    Failure to prepare or maintain accurate case histories with respect to observations and data…

The full 483

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This inspection in context

Questions about this 483

What did FDA find at Frederick J. Raal, FCP(SA), PhD, MD?

FDA listed 1 observation on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 312.62 (investigator recordkeeping and record retention). The opening words of each observation are shown on this page.

Who inspected Frederick J. Raal, FCP(SA), PhD, MD?

Angelica M. Chica is named on this Form 483, for the inspection of Sep 1 – Sep 4, 2025. Each investigator has a profile showing what they cite most.

When was Frederick J. Raal, FCP(SA), PhD, MD inspected by FDA?

The inspection ran Sep 1 – Sep 4, 2025, and the Form 483 is dated September 4, 2025.

How do I get the full Form 483 for Frederick J. Raal, FCP(SA), PhD, MD?

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