BioMed Laboratories, LLC
Form 483 issued October 31, 2025 · Dallas, Texas
- Inspection
- Oct 27 – Oct 31, 2025
- Investigators
- Margaret M. Annes· Mercedes N. Overton
- Observations
- 7
- Pages
- 10
- FEI number
- 3006784948
In short: On October 31, 2025, FDA issued a Form 483 with 7 observations to BioMed Laboratories, LLC in Dallas, Texas (FEI 3006784948) after an inspection that ran Oct 27 – Oct 31, 2025. The investigators were Margaret M. Annes and Mercedes N. Overton. Most observations concern laboratory controls and quality system.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
There is no written testing program designed to assess the stability…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
- 04
EMPLOYEEIS; SSHMURE The responsibilities and procedures applicable to the quality con trol unit are not in…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmBioMed Laboratories, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BioMed Laboratories, LLC?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, quality system and materials. The opening words of each observation are shown on this page.
Who inspected BioMed Laboratories, LLC?
Margaret M. Annes and Mercedes N. Overton are named on this Form 483, for the inspection of Oct 27 – Oct 31, 2025. Each investigator has a profile showing what they cite most.
When was BioMed Laboratories, LLC inspected by FDA?
The inspection ran Oct 27 – Oct 31, 2025, and the Form 483 is dated October 31, 2025.
How do I get the full Form 483 for BioMed Laboratories, 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.