Nova-Tech, Inc.
Form 483 issued March 15, 2022 · Grand Island, Nebraska
- Inspection
- Mar 15, 2022
- Investigators
- Lisa L. Flores· Robert J. Ham· Susanna E. Ford
- Observations
- 7
- Pages
- 10
- FEI number
- 1931182
In short: On March 15, 2022, FDA issued a Form 483 with 7 observations to Nova-Tech, Inc. in Grand Island, Nebraska (FEI 1931182) after an inspection that ran Mar 15, 2022. The investigators were Lisa L. Flores, Robert J. Ham and Susanna E. Ford. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 02
Complaint records are deficient in that they do not include the findings of the…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Lisa L. Flores
20 documents · 2012–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmNova-Tech, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nova-Tech, Inc.?
FDA listed 7 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Nova-Tech, Inc.?
Lisa L. Flores, Robert J. Ham and Susanna E. Ford are named on this Form 483, for the inspection of Mar 15, 2022. Each investigator has a profile showing what they cite most.
When was Nova-Tech, Inc. inspected by FDA?
The inspection ran Mar 15, 2022, and the Form 483 is dated March 15, 2022.
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.