Exel I nc. dba DHL Supply Chain (USA)

Form 483 issued November 25, 2024 · Lockbourne, Ohio

Inspection
Nov 15 – Nov 25, 2024
Observations
7
Pages
6
FEI number
3014922506

In short: On November 25, 2024, FDA issued a Form 483 with 7 observations to Exel I nc. dba DHL Supply Chain (USA) in Lockbourne, Ohio (FEI 3014922506) after an inspection that ran Nov 15 – Nov 25, 2024. The investigator was Ucheabuchi C. Chudi-Nwankwor. Most observations concern quality system and production.

At a glance

Observations span 4 systems, led by quality system.

Quality system3
Production1
Packaging & labeling1
Facilities & equipment1
Other1

What FDA observed

Preview: the opening words of each observation
  1. 01

    Your firm failed to establish written procedures for production and process controls designed to assure that…

  2. 02

    Written records of investigations into unexplained discrepancies and the failure of a batch or any of…

  3. 03

    The procedures for the annual quality standards record evaluation are deficient hr that they do not…

  4. 04

    Procedures describing in sufficient detail the controls employed for the issuance of…

3 more observations

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 Exel I nc. dba DHL Supply Chain (USA)?

FDA listed 7 observations on this Form 483, mostly about quality system, production and packaging & labeling. The opening words of each observation are shown on this page.

Who inspected Exel I nc. dba DHL Supply Chain (USA)?

Ucheabuchi C. Chudi-Nwankwor is named on this Form 483, for the inspection of Nov 15 – Nov 25, 2024. Each investigator has a profile showing what they cite most.

When was Exel I nc. dba DHL Supply Chain (USA) inspected by FDA?

The inspection ran Nov 15 – Nov 25, 2024, and the Form 483 is dated November 25, 2024.

How do I get the full Form 483 for Exel I nc. dba DHL Supply Chain (USA)?

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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