Dyna Labs, LLC
Form 483 issued September 26, 2019 · Saint Louis, Missouri
- Inspection
- Sep 9 – Sep 26, 2019
- Investigators
- Emilie Kahn· Michael G. Truchan· Nicole A. Lloyd
- Observations
- 4
- Pages
- 11
- FEI number
- 3005115360
In short: On September 26, 2019, FDA issued a Form 483 with 4 observations to Dyna Labs, LLC in Saint Louis, Missouri (FEI 3005115360) after an inspection that ran Sep 9 – Sep 26, 2019. The investigators were Emilie Kahn, Michael G. Truchan and Nicole A. Lloyd. Most observations concern laboratory controls and quality system.
At a glance
3 of 4 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
The accmacy, specificity and reproducibility of test methods have not…
- 02
The written stability program for drug products does not include reliable, meaningful…
- 03
Deviations from written specifications, standards, test procedures and laboratory mechanisms are…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Emilie Kahn
15 documents · 2016–2019
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Michigan.
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 211.165(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dyna Labs, LLC?
FDA listed 4 observations on this Form 483, mostly about laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Dyna Labs, LLC?
Emilie Kahn, Michael G. Truchan and Nicole A. Lloyd are named on this Form 483, for the inspection of Sep 9 – Sep 26, 2019. Each investigator has a profile showing what they cite most.
When was Dyna Labs, LLC inspected by FDA?
The inspection ran Sep 9 – Sep 26, 2019, and the Form 483 is dated September 26, 2019.
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.