Bajaj Medical, LLC
Form 483 issued October 16, 2015 · Chicago, Illinois
- Inspection
- Oct 5 – Oct 16, 2015
- Investigator
- Brian D. Nicholson
- Observations
- 4
- Pages
- 2
- FEI number
- 3010164083
In short: On October 16, 2015, FDA issued a Form 483 with 4 observations to Bajaj Medical, LLC in Chicago, Illinois (FEI 3010164083) after an inspection that ran Oct 5 – Oct 16, 2015. The investigator was Brian D. Nicholson. Most observations concern quality system and laboratory controls.
At a glance
3 of 4 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The written stability testing…
- 02
Written procedures are not established for evaluations conducted at least annually to review records associated with…
- 03
Written records of investigations into do not include…
- 04
Procedures describing the handling of written and oral complaints related to drug products are…
This inspection in context
Brian D. Nicholson
20 documents · 2013–2022
Cites 211.113 (control of microbiological contamination) 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 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bajaj Medical, LLC?
FDA listed 4 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Bajaj Medical, LLC?
Brian D. Nicholson is named on this Form 483, for the inspection of Oct 5 – Oct 16, 2015. Each investigator has a profile showing what they cite most.
When was Bajaj Medical, LLC inspected by FDA?
The inspection ran Oct 5 – Oct 16, 2015, and the Form 483 is dated October 16, 2015.
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.