Future Pak LLC
Form 483 issued October 15, 2024 · Wixom, Michigan
- Inspection
- Oct 7 – Oct 15, 2024
- Investigators
- Joseph A. Piechocki· Ramia Brzenjy· Supreet K. Sran
- Observations
- 6
- Pages
- 11
- FEI number
- 1824909
In short: On October 15, 2024, FDA issued a Form 483 with 6 observations to Future Pak LLC in Wixom, Michigan (FEI 1824909) after an inspection that ran Oct 7 – Oct 15, 2024. The investigators were Joseph A. Piechocki, Ramia Brzenjy and Supreet K. Sran. Most observations concern production and quality system.
At a glance
Production and quality system account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Established specifications, sampling plans and test…
- 02
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 03
Written production and process control procedures are not followed in the execution of production…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Joseph A. Piechocki
19 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmFuture Pak 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 211.160(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Future Pak LLC?
FDA listed 6 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Future Pak LLC?
Joseph A. Piechocki, Ramia Brzenjy and Supreet K. Sran are named on this Form 483, for the inspection of Oct 7 – Oct 15, 2024. Each investigator has a profile showing what they cite most.
When was Future Pak LLC inspected by FDA?
The inspection ran Oct 7 – Oct 15, 2024, and the Form 483 is dated October 15, 2024.
How do I get the full Form 483 for Future Pak 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.