PJM World Wide LLC
Form 483 issued November 4, 2024 · Doral, Florida
- Inspection
- Oct 21 – Nov 4, 2024
- Investigators
- Alex J. Wild· Benjamin W. Anderson· Jocelyn C. Turner
- Observations
- 10
- Pages
- 27
- FEI number
- 3015042181
In short: On November 4, 2024, FDA issued a Form 483 with 10 observations to PJM World Wide LLC in Doral, Florida (FEI 3015042181) after an inspection that ran Oct 21 – Nov 4, 2024. The investigators were Alex J. Wild, Benjamin W. Anderson, Jocelyn C. Turner and Marvin A. Marenco. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process controls account for 6 of 10 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 02
Procedures for design control…
- 03
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 04
Procedures or instructions for performing servicing activities and verifying that servicing meets specified requirements…
This inspection in context
Alex J. Wild
4 documents · 2023–2026
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Florida.
The firmPJM World Wide LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PJM World Wide LLC?
FDA listed 10 observations on this Form 483, mostly about cAPA, production & process controls and design controls. The opening words of each observation are shown on this page.
Who inspected PJM World Wide LLC?
Alex J. Wild, Benjamin W. Anderson, Jocelyn C. Turner and Marvin A. Marenco are named on this Form 483, for the inspection of Oct 21 – Nov 4, 2024. Each investigator has a profile showing what they cite most.
When was PJM World Wide LLC inspected by FDA?
The inspection ran Oct 21 – Nov 4, 2024, and the Form 483 is dated November 4, 2024.
How do I get the full Form 483 for PJM World Wide 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.