Bioduro LLC
Form 483 issued February 23, 2024 · Irvine, California
- Inspection
- Feb 12 – Feb 23, 2024
- Investigator
- Bryan A. Galvez
- Observations
- 8
- Pages
- 7
- FEI number
- 3004492248
In short: On February 23, 2024, FDA issued a Form 483 with 8 observations to Bioduro LLC in Irvine, California (FEI 3004492248) after an inspection that ran Feb 12 – Feb 23, 2024. The investigator was Bryan A. Galvez. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Quality system and laboratory controls account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 04
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
This inspection in context
Bryan A. Galvez
15 documents · 2018–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bioduro LLC?
FDA listed 8 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Bioduro LLC?
Bryan A. Galvez is named on this Form 483, for the inspection of Feb 12 – Feb 23, 2024. Each investigator has a profile showing what they cite most.
When was Bioduro LLC inspected by FDA?
The inspection ran Feb 12 – Feb 23, 2024, and the Form 483 is dated February 23, 2024.
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.