Den-Mat Holdings, LLC dba Clinician's Choice
Form 483 issued December 7, 2023 · Lompoc, California
- Investigator
- Youkeun Kim
- Observations
- 2
- Pages
- 3
- FEI number
- 2018957
In short: On December 7, 2023, FDA issued a Form 483 with 2 observations to Den-Mat Holdings, LLC dba Clinician's Choice in Lompoc, California (FEI 2018957). The investigator was Youkeun Kim. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.22(d) (1×) · 211.84(d)(2) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
This inspection in context
Youkeun Kim
13 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in California.
The firmDen-Mat Holdings, LLC dba Clinician's Choice history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Den-Mat Holdings, LLC dba Clinician's Choice?
FDA listed 2 observations on this Form 483, mostly about quality system and materials. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Den-Mat Holdings, LLC dba Clinician's Choice?
Youkeun Kim is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Den-Mat Holdings, LLC dba Clinician's Choice inspected by FDA?
This Form 483 is dated December 7, 2023.
How do I get the full Form 483 for Den-Mat Holdings, LLC dba Clinician's Choice?
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.