Berkeley Advanced Biomaterials, LLC
Form 483 issued November 22, 2024
- Inspection
- Nov 18 – Nov 22, 2024
- Investigator
- Emily S. McGann
- Observations
- 3
- Pages
- 4
- FEI number
- 3014298539
In short: On November 22, 2024, FDA issued a Form 483 with 3 observations to Berkeley Advanced Biomaterials, LLC (FEI 3014298539) after an inspection that ran Nov 18 – Nov 22, 2024. The investigator was Emily S. McGann. Most observations concern hCT/P.
At a glance
3 of 3 observations on this 483 concern hct/p.
What FDA observed
Preview: the opening words of each observation- 01
HCT/Ps were not processed in a way that does not cause contamination or…
- 02
Environmental conditions are not monitored when such conditions could cause contamination or cross contamination…
- 03
Records were not detailed as necessary to provide a complete…
This inspection in context
Emily S. McGann
6 documents · 2024–2026
Cites 1271.50 (how do i determine whether a donor is eligible?) more than any other section. Most of their documents are for sites in Arizona.
The firmBerkeley Advanced Biomaterials, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 1271.220(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Berkeley Advanced Biomaterials, LLC?
FDA listed 3 observations on this Form 483, mostly about hCT/P. The opening words of each observation are shown on this page.
Who inspected Berkeley Advanced Biomaterials, LLC?
Emily S. McGann is named on this Form 483, for the inspection of Nov 18 – Nov 22, 2024. Each investigator has a profile showing what they cite most.
When was Berkeley Advanced Biomaterials, LLC inspected by FDA?
The inspection ran Nov 18 – Nov 22, 2024, and the Form 483 is dated November 22, 2024.
How do I get the full Form 483 for Berkeley Advanced Biomaterials, 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.