Future Pak LLC
FDA inspection history in Wixom, Michigan, 2019 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Wixom, Michigan.
- 2024One Form 483, at Wixom, Michigan.
- 2024The longest 483 on file: 6 observations over 11 pages at Wixom, Michigan.
Cited most
Across all Future Pak observations on file
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.100(b)Written procedures; deviations1
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.160(a)General requirements1
The complete Future Pak file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Wixom, Michigan
Two Form 483s · 2019 to 2024 · 10 observations
Latest: Form 483, Oct 15, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-10-15 | 483 Form 483 | Wixom, Michigan | 6 | $99 |
| 2019-12-12 | 483 Form 483 | Wixom, Michigan | 4 | $99 |
Investigators on these documents
Joseph A. Piechocki (1)Ramia Brzenjy (1)Sarah E. Rhoades (1)Supreet K. Sran (1)
FEI number 1824909 · most recent document Oct 15, 2024
About Future Pak LLC
How many FDA Form 483s has Future Pak LLC received?
FDA Intel has 2 Form 483s on file for Future Pak LLC; the most recent is dated Oct 15, 2024.
When was Future Pak LLC last inspected by FDA?
The most recent FDA inspection document on file for Future Pak LLC is a Form 483 dated Oct 15, 2024, for the site in Wixom, Michigan.
What did FDA cite at Future Pak LLC?
The regulations cited most in the observations on file for Future Pak LLC are 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.100(b) (Written procedures; deviations), 1 time.