YB CHEMIA LLC
Form 483 issued October 24, 2024 · Baldwin Park, California
- Inspection
- Oct 21 – Oct 24, 2024
- Investigator
- Youkeun Kim
- Observations
- 2
- Pages
- 3
- FEI number
- 3017645574
In short: On October 24, 2024, FDA issued a Form 483 with 2 observations to YB CHEMIA LLC in Baldwin Park, California (FEI 3017645574) after an inspection that ran Oct 21 – Oct 24, 2024. The investigator was Youkeun Kim. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.22(d) (1×) · 211.63 (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
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
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 firmYB CHEMIA LLC 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 YB CHEMIA LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. 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 YB CHEMIA LLC?
Youkeun Kim is named on this Form 483, for the inspection of Oct 21 – Oct 24, 2024. Each investigator has a profile showing what they cite most.
When was YB CHEMIA LLC inspected by FDA?
The inspection ran Oct 21 – Oct 24, 2024, and the Form 483 is dated October 24, 2024.
How do I get the full Form 483 for YB CHEMIA LLC?
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.