Solomon Park Research Laboratories, Inc.
Form 483 issued January 8, 2026 · Burien, Washington
- Inspection
- Jan 5 – Jan 8, 2026
- Investigator
- Brian R. Hendricks
- Observations
- 3
- Pages
- 4
- FEI number
- 3023437
In short: On January 8, 2026, FDA issued a Form 483 with 3 observations to Solomon Park Research Laboratories, Inc. in Burien, Washington (FEI 3023437) after an inspection that ran Jan 5 – Jan 8, 2026. The investigator was Brian R. Hendricks. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?).
At a glance
2 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Written MDR procedures have not…
- 0221 CFR 830
The labels of the medical device(s) do not bear a unique device identifier (UDI) that meet…
- 03
Procedures that define the responsibility for review and the authority for the disposition of nonconforming product…
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 firmSolomon Park Research Laboratories, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Solomon Park Research Laboratories, Inc.?
FDA listed 3 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?). The opening words of each observation are shown on this page.
Who inspected Solomon Park Research Laboratories, Inc.?
Brian R. Hendricks is named on this Form 483, for the inspection of Jan 5 – Jan 8, 2026. Each investigator has a profile showing what they cite most.
When was Solomon Park Research Laboratories, Inc. inspected by FDA?
The inspection ran Jan 5 – Jan 8, 2026, and the Form 483 is dated January 8, 2026.
How do I get the full Form 483 for Solomon Park Research Laboratories, Inc.?
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