Belt Power LLC
Form 483 issued October 29, 2024 · Grand Rapids, Michigan
- Inspection
- Oct 29, 2024
- Investigators
- Jacob G. Lutz· Ramia Brzenjy
- Observations
- 3
- Pages
- 4
- FEI number
- 3000913784
In short: On October 29, 2024, FDA issued a Form 483 with 3 observations to Belt Power LLC in Grand Rapids, Michigan (FEI 3000913784) after an inspection that ran Oct 29, 2024. The investigators were Jacob G. Lutz and Ramia Brzenjy. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
The establishment of specifications, standards, sampling plans, test procedures and laboratory control mechanisms including any changes…
- 03
Procedures describing in sufficient detail the controls employed for the issuance of…
This inspection in context
Jacob G. Lutz
14 documents · 2019–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Michigan.
The firmBelt Power LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Belt Power LLC?
FDA listed 3 observations on this Form 483, mostly about quality system, laboratory controls and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Belt Power LLC?
Jacob G. Lutz and Ramia Brzenjy are named on this Form 483, for the inspection of Oct 29, 2024. Each investigator has a profile showing what they cite most.
When was Belt Power LLC inspected by FDA?
The inspection ran Oct 29, 2024, and the Form 483 is dated October 29, 2024.
How do I get the full Form 483 for Belt Power 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.