Orient Pharma Co., Ltd. Yunlin Plant
Form 483 issued September 7, 2022 · Huwei Township, Taiwan
- Inspection
- Aug 31 – Sep 7, 2022
- Investigator
- Kham Phommachanh
- Observations
- 2
- Pages
- 1
- FEI number
- 3009057557
In short: On September 7, 2022, FDA issued a Form 483 with 2 observations to Orient Pharma Co., Ltd. Yunlin Plant in Huwei Township, Yunlin County (FEI 3009057557) after an inspection that ran Aug 31 – Sep 7, 2022. The investigator was Kham Phommachanh. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
Production and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.188 (1×) · 211.56 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The batch production and control records are deficient in that they do not include documentation of…
- 02
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
This inspection in context
Kham Phommachanh
12 documents · 2009–2024
Cites 211.194 (laboratory records) more than any other section. Most of their documents are for sites in Canada.
The firmOrient Pharma Co., Ltd. Yunlin Plant history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Orient Pharma Co., Ltd. Yunlin Plant?
FDA listed 2 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected Orient Pharma Co., Ltd. Yunlin Plant?
Kham Phommachanh is named on this Form 483, for the inspection of Aug 31 – Sep 7, 2022. Each investigator has a profile showing what they cite most.
When was Orient Pharma Co., Ltd. Yunlin Plant inspected by FDA?
The inspection ran Aug 31 – Sep 7, 2022, and the Form 483 is dated September 7, 2022.
How do I get the full Form 483 for Orient Pharma Co., Ltd. Yunlin Plant?
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