HUBOT, INC.
Form 483 issued November 8, 2024 · SOUTH BEND, Indiana
- Investigator
- Nicholas J. Presto
- Observations
- 1
- Pages
- 2
- FEI number
- 3015177815
In short: On November 8, 2024, FDA issued a Form 483 with 1 observation to HUBOT, INC. in SOUTH BEND, Indiana (FEI 3015177815). The investigator was Nicholas J. Presto. Most observations concern materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.84(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The number of containers to be sampled is not…
This inspection in context
Nicholas J. Presto
10 documents · 2023–2026
Cites 211.188 (batch production and control records) more than any other section. Most of their documents are for sites in Michigan.
The firmHUBOT, INC. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at HUBOT, INC.?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected HUBOT, INC.?
Nicholas J. Presto is named on this Form 483. Each investigator has a profile showing what they cite most.
When was HUBOT, INC. inspected by FDA?
This Form 483 is dated November 8, 2024.
How do I get the full Form 483 for HUBOT, INC.?
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.