Bioduro LLC
Form 483 issued September 6, 2019 · Irvine, California
- Inspection
- Sep 3 – Sep 6, 2019
- Investigator
- Linda F. Murphy
- Observations
- 4
- Pages
- 4
- FEI number
- 3004492248
In short: On September 6, 2019, FDA issued a Form 483 with 4 observations to Bioduro LLC in Irvine, California (FEI 3004492248) after an inspection that ran Sep 3 – Sep 6, 2019. The investigator was Linda F. Murphy. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 02
Laboratory records are deficient in that they do not include all…
- 03
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Linda F. Murphy
23 documents · 2015–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in India.
The firmBioduro 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 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bioduro LLC?
FDA listed 4 observations on this Form 483, mostly about laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Bioduro LLC?
Linda F. Murphy is named on this Form 483, for the inspection of Sep 3 – Sep 6, 2019. Each investigator has a profile showing what they cite most.
When was Bioduro LLC inspected by FDA?
The inspection ran Sep 3 – Sep 6, 2019, and the Form 483 is dated September 6, 2019.
How do I get the full Form 483 for Bioduro 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.