Yiling Pharmaceutical Ltd.
Form 483 issued October 11, 2024 · Shijiazhuang, China
- Investigator
- Patty P. Kaewussdangkul
- Observations
- 3
- Pages
- 2
- FEI number
- 3011640199
In short: On October 11, 2024, FDA issued a Form 483 with 3 observations to Yiling Pharmaceutical Ltd. in Shijiazhuang, China (FEI 3011640199). The investigator was Patty P. Kaewussdangkul. Most observations concern materials and facilities & equipment; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
2 of 3 observations on this 483 concern materials.
Most cited: 21 CFR 211.84 (2×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
- 02
Each lot of components is not withheld from use until the lot has been sampled, tested…
- 03
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
This inspection in context
Patty P. Kaewussdangkul
54 documents · 2006–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmYiling Pharmaceutical Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Yiling Pharmaceutical Ltd.?
FDA listed 3 observations on this Form 483, mostly about materials and facilities & equipment. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Yiling Pharmaceutical Ltd.?
Patty P. Kaewussdangkul is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Yiling Pharmaceutical Ltd. inspected by FDA?
This Form 483 is dated October 11, 2024.
How do I get the full Form 483 for Yiling Pharmaceutical Ltd.?
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.