Rebel Converting, LLC
Form 483 issued February 24, 2025 · Milwaukee, Wisconsin
- Inspection
- Dec 3, 2024 – Feb 24, 2025
- Investigators
- Joohi Castelvetere· Tyler Peterson· Vaishali J. Patel
- Observations
- 6
- Pages
- 28
- FEI number
- 3010166020
In short: On February 24, 2025, FDA issued a Form 483 with 6 observations to Rebel Converting, LLC in Milwaukee, Wisconsin (FEI 3010166020) after an inspection that ran Dec 3, 2024 – Feb 24, 2025. The investigators were Joohi Castelvetere, Tyler Peterson and Vaishali J. Patel. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and laboratory controls account for 4 of 6 observations.
Most cited: 21 CFR 211.67 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to establish a written testing program that is designed to assess the stability…
- 02
Sampling plans and procedures designed to validate the performance of manufacturing processes that may be responsible…
- 03
Failure to perform cleaning validation studies to identify and evaluate the hardest-to-clean product in your manufacturing…
- 04
Failure to document, investigate, and explain any…
This inspection in context
Joohi Castelvetere
9 documents · 2024–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Indiana.
The firmRebel Converting, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Rebel Converting, LLC?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Rebel Converting, LLC?
Joohi Castelvetere, Tyler Peterson and Vaishali J. Patel are named on this Form 483, for the inspection of Dec 3, 2024 – Feb 24, 2025. Each investigator has a profile showing what they cite most.
When was Rebel Converting, LLC inspected by FDA?
The inspection ran Dec 3, 2024 – Feb 24, 2025, and the Form 483 is dated February 24, 2025.
How do I get the full Form 483 for Rebel Converting, 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.