Vitality Works, Inc.
Form 483 issued August 5, 2022 · Albuquerque, New Mexico
- Inspection
- Aug 1 – Aug 5, 2022
- Investigators
- Dustin M. James· Matthew R. Clabeaux
- Observations
- 7
- Pages
- 10
- FEI number
- 3000719151
In short: On August 5, 2022, FDA issued a Form 483 with 7 observations to Vitality Works, Inc. in Albuquerque, New Mexico (FEI 3000719151) after an inspection that ran Aug 1 – Aug 5, 2022. The investigators were Dustin M. James and Matthew R. Clabeaux. Most observations concern quality system and materials.
At a glance
Quality system and materials account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Component testing is deficient in that each component is not tested for conformity with all appropriate…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment…
- 04
Employees engaged in the manufacture and processing of a drug product lack the training required to…
This inspection in context
Dustin M. James
4 documents · 2021–2022
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmVitality Works, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84(d)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Vitality Works, Inc.?
FDA listed 7 observations on this Form 483, mostly about quality system, materials and production. The opening words of each observation are shown on this page.
Who inspected Vitality Works, Inc.?
Dustin M. James and Matthew R. Clabeaux are named on this Form 483, for the inspection of Aug 1 – Aug 5, 2022. Each investigator has a profile showing what they cite most.
When was Vitality Works, Inc. inspected by FDA?
The inspection ran Aug 1 – Aug 5, 2022, and the Form 483 is dated August 5, 2022.
How do I get the full Form 483 for Vitality Works, Inc.?
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.