VHA Office of Advanced Manufacturing
Form 483 issued January 23, 2025 · Seattle, Washington
- Inspection
- Jan 16 – Jan 23, 2025
- Investigator
- Brian R. Hendricks
- Observations
- 4
- Pages
- 6
- FEI number
- 3004073926
In short: On January 23, 2025, FDA issued a Form 483 with 4 observations to VHA Office of Advanced Manufacturing in Seattle, Washington (FEI 3004073926) after an inspection that ran Jan 16 – Jan 23, 2025. The investigator was Brian R. Hendricks. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Corrective and preventive action activities and/or results have…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 03
Records of acceptable suppliers have…
- 04
Procedures for quality audits have…
This inspection in context
Brian R. Hendricks
6 documents · 2024–2026
Cites 820.10 (requirements for a quality management system) more than any other section. Most of their documents are for sites in Washington.
The firmVHA Office of Advanced Manufacturing history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at VHA Office of Advanced Manufacturing?
FDA listed 4 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 VHA Office of Advanced Manufacturing?
Brian R. Hendricks is named on this Form 483, for the inspection of Jan 16 – Jan 23, 2025. Each investigator has a profile showing what they cite most.
When was VHA Office of Advanced Manufacturing inspected by FDA?
The inspection ran Jan 16 – Jan 23, 2025, and the Form 483 is dated January 23, 2025.
How do I get the full Form 483 for VHA Office of Advanced Manufacturing?
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.