PharmaEssentia Corporation, Taichung Plant
Form 483 issued April 18, 2023 · Taichung, Taiwan
- Inspection
- Apr 10 – Apr 18, 2023
- Investigator
- Jeffrey P. Raimondi
- Observations
- 2
- Pages
- 1
- FEI number
- 2000012832
In short: On April 18, 2023, FDA issued a Form 483 with 2 observations to PharmaEssentia Corporation, Taichung Plant in Taichung, Taiwan (FEI 2000012832) after an inspection that ran Apr 10 – Apr 18, 2023. The investigator was Jeffrey P. Raimondi. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.198 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The investigations into complaints onic: to lack of therapeutic efficacy, do not include a review of…
- 02
The method for performing bacterial endotoxin testing by Kinetic Turbidimetric LAL Assay…
This inspection in context
Jeffrey P. Raimondi
40 documents · 2017–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmPharmaEssentia Corporation, Taichung Plant history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PharmaEssentia Corporation, Taichung Plant?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected PharmaEssentia Corporation, Taichung Plant?
Jeffrey P. Raimondi is named on this Form 483, for the inspection of Apr 10 – Apr 18, 2023. Each investigator has a profile showing what they cite most.
When was PharmaEssentia Corporation, Taichung Plant inspected by FDA?
The inspection ran Apr 10 – Apr 18, 2023, and the Form 483 is dated April 18, 2023.
How do I get the full Form 483 for PharmaEssentia Corporation, Taichung Plant?
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