Yangzhou Liberty Pharmaceutical Co., Ltd
Form 483 issued September 15, 2023 · Yangzhou, China
- Inspection
- Sep 11 – Sep 15, 2023
- Investigator
- Patty P. Kaewussdangkul
- Observations
- 1
- Pages
- 1
- FEI number
- 3009261735
In short: On September 15, 2023, FDA issued a Form 483 with 1 observation to Yangzhou Liberty Pharmaceutical Co., Ltd in Yangzhou, Jiangsu (FEI 3009261735) after an inspection that ran Sep 11 – Sep 15, 2023. The investigator was Patty P. Kaewussdangkul. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 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
Accessory equipment used in the production of active pharmaceutical ingredients…
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 firmYangzhou Liberty Pharmaceutical Co., Ltd history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Yangzhou Liberty Pharmaceutical Co., Ltd?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Yangzhou Liberty Pharmaceutical Co., Ltd?
Patty P. Kaewussdangkul is named on this Form 483, for the inspection of Sep 11 – Sep 15, 2023. Each investigator has a profile showing what they cite most.
When was Yangzhou Liberty Pharmaceutical Co., Ltd inspected by FDA?
The inspection ran Sep 11 – Sep 15, 2023, and the Form 483 is dated September 15, 2023.
How do I get the full Form 483 for Yangzhou Liberty Pharmaceutical Co., Ltd?
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