Future Pak LLC
Form 483 issued December 12, 2019 · Wixom, Michigan
- Investigator
- Sarah E. Rhoades
- Observations
- 4
- Pages
- 5
- FEI number
- 1824909
In short: On December 12, 2019, FDA issued a Form 483 with 4 observations to Future Pak LLC in Wixom, Michigan (FEI 1824909). The investigator was Sarah E. Rhoades. Most observations concern facilities & equipment and quality system.
At a glance
3 of 4 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
The building lacks adequate space for the orderly placement of equipment and materials to prevent mix…
- 03
Routine checking of equipment is not performed according to a written program designed…
- 04
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
This inspection in context
Sarah E. Rhoades
14 documents · 2017–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Michigan.
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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Future Pak LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Future Pak LLC?
Sarah E. Rhoades is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Future Pak LLC inspected by FDA?
This Form 483 is dated December 12, 2019.
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.