Ace Products & Consulting LLC
Form 483 issued April 4, 2024 · Ravenna, Ohio
- Inspection
- Apr 2 – Apr 4, 2024
- Investigator
- Logan T. Williams
- Observations
- 3
- Pages
- 3
- FEI number
- 3018063357
In short: On April 4, 2024, FDA issued a Form 483 with 3 observations to Ace Products & Consulting LLC in Ravenna, Ohio (FEI 3018063357) after an inspection that ran Apr 2 – Apr 4, 2024. The investigator was Logan T. Williams. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written records are not made of investigations into unexplained discrepancies and the failure of a batch…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Written production and process control procedures are not documented at…
This inspection in context
Logan T. Williams
32 documents · 2020–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kentucky.
The firmAce Products & Consulting LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ace Products & Consulting LLC?
FDA listed 3 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Ace Products & Consulting LLC?
Logan T. Williams is named on this Form 483, for the inspection of Apr 2 – Apr 4, 2024. Each investigator has a profile showing what they cite most.
When was Ace Products & Consulting LLC inspected by FDA?
The inspection ran Apr 2 – Apr 4, 2024, and the Form 483 is dated April 4, 2024.
How do I get the full Form 483 for Ace Products & Consulting 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.