Hudson Scientific LLC
Form 483 issued August 7, 2018 · Hudson, Michigan
- Inspection
- Jul 31 – Aug 7, 2018
- Investigator
- Sarah E. Rhoades
- Observations
- 1
- Pages
- 7
- FEI number
- 3013037032
In short: On August 7, 2018, FDA issued a Form 483 with 1 observation to Hudson Scientific LLC in Hudson, Michigan (FEI 3013037032) after an inspection that ran Jul 31 – Aug 7, 2018. The investigator was Sarah E. Rhoades. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
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 firmHudson Scientific 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 Hudson Scientific LLC?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Hudson Scientific LLC?
Sarah E. Rhoades is named on this Form 483, for the inspection of Jul 31 – Aug 7, 2018. Each investigator has a profile showing what they cite most.
When was Hudson Scientific LLC inspected by FDA?
The inspection ran Jul 31 – Aug 7, 2018, and the Form 483 is dated August 7, 2018.
How do I get the full Form 483 for Hudson Scientific 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.