Dyna Labs, LLC
Form 483 issued November 13, 2012 · St. Louis, Missouri
- Inspection
- Oct 25 – Nov 13, 2012
- Investigators
- H. Hunt· Jeremy W. Rotton
- Observations
- 5
- Pages
- 5
- FEI number
- 3005115360
In short: On November 13, 2012, FDA issued a Form 483 with 5 observations to Dyna Labs, LLC in St. Louis, Missouri (FEI 3005115360) after an inspection that ran Oct 25 – Nov 13, 2012. The investigators were H. Hunt and Jeremy W. Rotton. Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
3 of 5 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Test procedures relative to appropriate laboratory testing for…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
The accuracy and sensit ivity of test methods have not been…
- 04
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
This inspection in context
H. Hunt
1 document · 2012
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Missouri.
The firmDyna Labs, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dyna Labs, LLC?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, materials and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Dyna Labs, LLC?
H. Hunt and Jeremy W. Rotton are named on this Form 483, for the inspection of Oct 25 – Nov 13, 2012. Each investigator has a profile showing what they cite most.
When was Dyna Labs, LLC inspected by FDA?
The inspection ran Oct 25 – Nov 13, 2012, and the Form 483 is dated November 13, 2012.
How do I get the full Form 483 for Dyna Labs, 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.