DynaFlex LTD
Form 483 issued April 18, 2018 · St Ann, Missouri
- Inspection
- Apr 10 – Apr 18, 2018
- Investigator
- Edward E. Lockwood
- Observations
- 7
- Pages
- 7
- FEI number
- 1937100
In short: On April 18, 2018, FDA issued a Form 483 with 7 observations to DynaFlex LTD in St Ann, Missouri (FEI 1937100) after an inspection that ran Apr 10 – Apr 18, 2018. The investigator was Edward E. Lockwood. Most observations concern production & process controls and records & documents.
At a glance
Production & process controls and records & documents account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for corrective and preventive action have…
- 02
Procedures for design control have…
- 03
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 04
A device master record…
This inspection in context
Edward E. Lockwood
5 documents · 2018–2024
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Missouri.
The firmDynaFlex LTD history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at DynaFlex LTD?
FDA listed 7 observations on this Form 483, mostly about production & process controls, records & documents and cAPA. The opening words of each observation are shown on this page.
Who inspected DynaFlex LTD?
Edward E. Lockwood is named on this Form 483, for the inspection of Apr 10 – Apr 18, 2018. Each investigator has a profile showing what they cite most.
When was DynaFlex LTD inspected by FDA?
The inspection ran Apr 10 – Apr 18, 2018, and the Form 483 is dated April 18, 2018.
How do I get the full Form 483 for DynaFlex LTD?
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.