Velocity Production and Packaging
Form 483 issued May 8, 2019 · Tempe, Arizona
- Inspection
- May 6 – May 8, 2019
- Investigator
- Erika V. Butler
- Observations
- 3
- Pages
- 4
- FEI number
- 3014736593
In short: On May 8, 2019, FDA issued a Form 483 with 3 observations to Velocity Production and Packaging in Tempe, Arizona (FEI 3014736593) after an inspection that ran May 6 – May 8, 2019. The investigator was Erika V. Butler. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 02
The written stability program for drug products does not include meaningful…
- 03
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Erika V. Butler
23 documents · 2007–2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
The firmVelocity Production and Packaging history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Velocity Production and Packaging?
FDA listed 3 observations on this Form 483, mostly about production, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Velocity Production and Packaging?
Erika V. Butler is named on this Form 483, for the inspection of May 6 – May 8, 2019. Each investigator has a profile showing what they cite most.
When was Velocity Production and Packaging inspected by FDA?
The inspection ran May 6 – May 8, 2019, and the Form 483 is dated May 8, 2019.
How do I get the full Form 483 for Velocity Production and Packaging?
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.