Nanovis LLC
Form 483 issued March 19, 2026 · Columbia City, Indiana
- Inspection
- Mar 16 – Mar 19, 2026
- Investigators
- Shawn Choi· Suyang Qin
- Observations
- 6
- Pages
- 14
- FEI number
- 3009446038
In short: On March 19, 2026, FDA issued a Form 483 with 6 observations to Nanovis LLC in Columbia City, Indiana (FEI 3009446038) after an inspection that ran Mar 16 – Mar 19, 2026. The investigators were Shawn Choi and Suyang Qin. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
5 of 6 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.70 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for validation of processes did not adeqi lately include statist! cal techniques with rationale for…
- 02
Production controls do not include implementation of monitoring and measurement of process parameters and…
- 03
Requirements for the work environment, and the procedures to monitor and control the work environment, were…
- 04
Purchasing information does not adequately descrit e or reference the product to be purchased, including requirements…
This inspection in context
Shawn Choi
4 documents · 2024–2026
Cites 820.20(a) (management responsibility) more than any other section. Most of their documents are for sites in Wisconsin.
The firmNanovis LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.70
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nanovis LLC?
FDA listed 6 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected Nanovis LLC?
Shawn Choi and Suyang Qin are named on this Form 483, for the inspection of Mar 16 – Mar 19, 2026. Each investigator has a profile showing what they cite most.
When was Nanovis LLC inspected by FDA?
The inspection ran Mar 16 – Mar 19, 2026, and the Form 483 is dated March 19, 2026.
How do I get the full Form 483 for Nanovis 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.