PACKAGE SOLUTIONS LLC
Form 483 issued June 18, 2024 · Pompano Beach, Florida
- Inspection
- Jun 10 – Jun 18, 2024
- Investigator
- Ebony D. Sanon
- Observations
- 10
- Pages
- 8
- FEI number
- 3006559549
In short: On June 18, 2024, FDA issued a Form 483 with 10 observations to PACKAGE SOLUTIONS LLC in Pompano Beach, Florida (FEI 3006559549) after an inspection that ran Jun 10 – Jun 18, 2024. The investigator was Ebony D. Sanon. Most observations concern cAPA and production & process controls.
At a glance
Observations span 4 systems, led by capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures have not been established to control product that does not…
- 02
Complaint files are not…
- 0321 CFR 820.30(j)21 CFR 820
Observation 3: scanned text, readable in the full document.
- 04
Document control procedures have…
This inspection in context
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 firmPACKAGE SOLUTIONS LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.90(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PACKAGE SOLUTIONS LLC?
FDA listed 10 observations on this Form 483, mostly about cAPA, production & process controls and management controls. The opening words of each observation are shown on this page.
Who inspected PACKAGE SOLUTIONS LLC?
Ebony D. Sanon is named on this Form 483, for the inspection of Jun 10 – Jun 18, 2024. Each investigator has a profile showing what they cite most.
When was PACKAGE SOLUTIONS LLC inspected by FDA?
The inspection ran Jun 10 – Jun 18, 2024, and the Form 483 is dated June 18, 2024.
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.