Integrated Biomedical Technology, Inc
Form 483 issued December 19, 2019 · Elkhart, Indiana
- Inspection
- Dec 17 – Dec 19, 2019
- Investigator
- Suyang Qin
- Observations
- 4
- Pages
- 5
- FEI number
- 1000139989
In short: On December 19, 2019, FDA issued a Form 483 with 4 observations to Integrated Biomedical Technology, Inc in Elkhart, Indiana (FEI 1000139989) after an inspection that ran Dec 17 – Dec 19, 2019. The investigator was Suyang Qin. Most observations concern cAPA and records & documents.
At a glance
Observations span 4 systems, led by capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for collective and preventive action have…
- 02
A device history record has…
- 03
Procedures to ensure equipment is routinely calibrated have…
- 04
Procedures for quality audits have…
This inspection in context
Suyang Qin
9 documents · 2015–2026
Cites 820.70 (production and process controls) more than any other section. Most of their documents are for sites in Indiana.
The firmIntegrated Biomedical Technology, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Integrated Biomedical Technology, Inc?
FDA listed 4 observations on this Form 483, mostly about cAPA, records & documents and production & process controls. The opening words of each observation are shown on this page.
Who inspected Integrated Biomedical Technology, Inc?
Suyang Qin is named on this Form 483, for the inspection of Dec 17 – Dec 19, 2019. Each investigator has a profile showing what they cite most.
When was Integrated Biomedical Technology, Inc inspected by FDA?
The inspection ran Dec 17 – Dec 19, 2019, and the Form 483 is dated December 19, 2019.
How do I get the full Form 483 for Integrated Biomedical Technology, 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.