PACKAGE SOLUTIONS LLC

Form 483 issued February 10, 2026 · Pompano Beach, Florida

Inspection: Feb 2 – Feb 10, 2026
Investigators: Ebony D. Sanon· Lorraine N. Williams
Observations: 8
Pages: 9
FEI number: 3006559549

In short: On February 10, 2026, FDA issued a Form 483 with 8 observations to PACKAGE SOLUTIONS LLC in Pompano Beach, Florida (FEI 3006559549) after an inspection that ran Feb 2 – Feb 10, 2026. The investigators were Ebony D. Sanon and Lorraine N. Williams.

What FDA observed

Preview: the opening words of each observation

01
Procedures for timely complaint handling do not adequately include requirements and responsibilities for receiving and recording…
02
A risk-based approach to the control of the appropriate processes needed for the quality management system…
03
Medical device files have not…
04
Procedures were not adequately documented for preserving the conformity of product to requirements during processing…

4 more observations

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

Get the full 483

This inspection in context

The investigator

Ebony D. Sanon

8 documents · 2022–2026

Cites 820.184 (device history record) more than any other section. Most of their documents are for sites in Florida.

The firm

PACKAGE SOLUTIONS LLC history

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

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Questions about this 483

What did FDA find at PACKAGE SOLUTIONS LLC?

FDA listed 8 observations on this Form 483. The opening words of each observation are shown on this page.

Who inspected PACKAGE SOLUTIONS LLC?

Ebony D. Sanon and Lorraine N. Williams are named on this Form 483, for the inspection of Feb 2 – Feb 10, 2026. Each investigator has a profile showing what they cite most.

When was PACKAGE SOLUTIONS LLC inspected by FDA?

The inspection ran Feb 2 – Feb 10, 2026, and the Form 483 is dated February 10, 2026.

How do I get the full Form 483 for PACKAGE SOLUTIONS LLC?

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.