Nova-Tech, Inc.
Form 483 issued May 12, 2023 · Grand Island, Nebraska
- Observations
- 2
- Pages
- 2
- FEI number
- 1931182
In short: On May 12, 2023, FDA issued a Form 483 with 2 observations to Nova-Tech, Inc. in Grand Island, Nebraska (FEI 1931182). Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and production account for 2 of 2 observations.
Most cited: 21 CFR 211.160(b) (1×) · 211.113(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Questions about this 483
What did FDA find at Nova-Tech, Inc.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Nova-Tech, Inc. inspected by FDA?
This Form 483 is dated May 12, 2023.
How do I get the full Form 483 for Nova-Tech, 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.