PharmaEssentia Corporation, Taichung Plant
Form 483 issued September 21, 2023 · Taichung, Taiwan
- Inspection
- Sep 13 – Sep 21, 2023
- Investigators
- Hamet Toure· Madushini Dharmasena
- Observations
- 9
- Pages
- 6
- FEI number
- 2000012832
In short: On September 21, 2023, FDA issued a Form 483 with 9 observations to PharmaEssentia Corporation, Taichung Plant in Taichung, Taiwan (FEI 2000012832) after an inspection that ran Sep 13 – Sep 21, 2023. The investigators were Hamet Toure and Madushini Dharmasena. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 6 of 9 observations.
Most cited: 21 CFR 211.113 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The visual inspection procedures are inadequate to address defective…
- 02
The air flow pattern testing studies did not include all operations such as setup and assembly…
- 03
Thel yyy arug product manufacturing process is not adequately controlled or monitored to ensure that process…
- 04
Procedures designed to prevent microbiological contamination of Parag product purporting to be sterile are…
This inspection in context
Hamet Toure
2 documents · 2022–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Malaysia.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PharmaEssentia Corporation, Taichung Plant?
FDA listed 9 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected PharmaEssentia Corporation, Taichung Plant?
Hamet Toure and Madushini Dharmasena are named on this Form 483, for the inspection of Sep 13 – Sep 21, 2023. Each investigator has a profile showing what they cite most.
When was PharmaEssentia Corporation, Taichung Plant inspected by FDA?
The inspection ran Sep 13 – Sep 21, 2023, and the Form 483 is dated September 21, 2023.
How do I get the full Form 483 for PharmaEssentia Corporation, Taichung Plant?
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