DB Biologics, LLC
Form 483 issued June 18, 2025
- Inspection
- Jun 16 – Jun 18, 2025
- Investigator
- Michele Gottshall
- Observations
- 1
- Pages
- 2
- FEI number
- 3006761306
In short: On June 18, 2025, FDA issued a Form 483 with 1 observation to DB Biologics, LLC (FEI 3006761306) after an inspection that ran Jun 16 – Jun 18, 2025. The investigator was Michele Gottshall. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 640.4 (collection of the blood).
At a glance
1 of 1 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 640.4 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The phlebotomy site is not prepared by a method that gives maximum assurance of a…
This inspection in context
Michele Gottshall
12 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmDB Biologics, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 640.4
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at DB Biologics, LLC?
FDA listed 1 observation on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 640.4 (collection of the blood). The opening words of each observation are shown on this page.
Who inspected DB Biologics, LLC?
Michele Gottshall is named on this Form 483, for the inspection of Jun 16 – Jun 18, 2025. Each investigator has a profile showing what they cite most.
When was DB Biologics, LLC inspected by FDA?
The inspection ran Jun 16 – Jun 18, 2025, and the Form 483 is dated June 18, 2025.
How do I get the full Form 483 for DB Biologics, 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.