Simpro, LLC
Form 483 issued July 7, 2016 · Irving, Texas
- Inspection
- Jun 17 – Jul 7, 2016
- Investigator
- Janete F. Guardia
- Observations
- 5
- Pages
- 3
- FEI number
- 3004485927
In short: On July 7, 2016, FDA issued a Form 483 with 5 observations to Simpro, LLC in Irving, Texas (FEI 3004485927) after an inspection that ran Jun 17 – Jul 7, 2016. The investigator was Janete F. Guardia. Most observations concern cAPA and production & process controls.
At a glance
3 of 5 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The procedures for implementing corrective and preventive…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 03
Written MDR procedures have not been…
- 04
Failure to establish and maintain procedures for the control of storage areas and stockrooms for product…
This inspection in context
Janete F. Guardia
4 documents · 2016–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in China.
The firmSimpro, 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 820.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Simpro, LLC?
FDA listed 5 observations on this Form 483, mostly about cAPA, production & process controls and management controls. The opening words of each observation are shown on this page.
Who inspected Simpro, LLC?
Janete F. Guardia is named on this Form 483, for the inspection of Jun 17 – Jul 7, 2016. Each investigator has a profile showing what they cite most.
When was Simpro, LLC inspected by FDA?
The inspection ran Jun 17 – Jul 7, 2016, and the Form 483 is dated July 7, 2016.
How do I get the full Form 483 for Simpro, 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.