Bajaj Medical, LLC
Form 483 issued October 1, 2019 · Chicago, Illinois
- Inspection
- Sep 24 – Oct 1, 2019
- Investigator
- Vioela J. Caze
- Observations
- 1
- Pages
- 2
- FEI number
- 3010164083
In short: On October 1, 2019, FDA issued a Form 483 with 1 observation to Bajaj Medical, LLC in Chicago, Illinois (FEI 3010164083) after an inspection that ran Sep 24 – Oct 1, 2019. The investigator was Vioela J. Caze. Most observations concern quality system; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.180(e)(2) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are not followed for evaluations done at least annually and including provisions for a…
This inspection in context
Vioela J. Caze
3 documents · 2019–2021
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Illinois.
The firmBajaj Medical, LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.180(e)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bajaj Medical, LLC?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected Bajaj Medical, LLC?
Vioela J. Caze is named on this Form 483, for the inspection of Sep 24 – Oct 1, 2019. Each investigator has a profile showing what they cite most.
When was Bajaj Medical, LLC inspected by FDA?
The inspection ran Sep 24 – Oct 1, 2019, and the Form 483 is dated October 1, 2019.
How do I get the full Form 483 for Bajaj Medical, 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.