PharmaEssentia Corporation, Taichung Plant
FDA inspection history in Taichung, Taiwan, 2023
- 2
- Form 483s
Every document, by year
- Form 483
2023: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2023Two Form 483s, at Taichung, Taiwan.
- 2023The longest 483 on file: 9 observations over 6 pages at Taichung, Taiwan.
Cited most
Across all PharmaEssentia Corporation, Taichung Plant observations on file
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.160General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.198Complaint files1
The complete PharmaEssentia Corporation, Taichung Plant file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Taichung, Taiwan
Two Form 483s · 2023 · 11 observations
Latest: Form 483, Sep 21, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-21 | 483 Form 483 | Taichung, Taiwan | 9 | $99 |
| 2023-04-18 | 483 Form 483 | Taichung, Taiwan | 2 | $99 |
Investigators on these documents
Hamet Toure (1)Jeffrey P. Raimondi (1)Madushini Dharmasena (1)
FEI number 2000012832 · most recent document Sep 21, 2023
About PharmaEssentia Corporation, Taichung Plant
How many FDA Form 483s has PharmaEssentia Corporation, Taichung Plant received?
FDA Intel has 2 Form 483s on file for PharmaEssentia Corporation, Taichung Plant; the most recent is dated Sep 21, 2023.
When was PharmaEssentia Corporation, Taichung Plant last inspected by FDA?
The most recent FDA inspection document on file for PharmaEssentia Corporation, Taichung Plant is a Form 483 dated Sep 21, 2023, for the site in Taichung, Taiwan.
What did FDA cite at PharmaEssentia Corporation, Taichung Plant?
The regulations cited most in the observations on file for PharmaEssentia Corporation, Taichung Plant are 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.160 (General requirements), 1 time.