Chunghwa Chemical Synthesis & Biotech Co., Ltd.
FDA inspection history in New Taipei City, Taiwan, 2022 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2022: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–24Two Form 483s, at New Taipei City, Taiwan.
- 2024The longest 483 on file: 3 observations over 2 pages at New Taipei City, Taiwan.
Cited most
Across all Chunghwa Chemical Synthesis & Biotech Co. observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.87Retesting of approved components, drug product containers, and closures1
The complete Chunghwa Chemical Synthesis & Biotech Co. 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
New Taipei City, Taiwan
Two Form 483s · 2022 to 2024 · 6 observations
Latest: Form 483, Apr 12, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-04-12 | 483 Form 483 | New Taipei City, Taiwan | 3 | $99 |
| 2022-11-18 | 483 Form 483 | New Taipei City, Taiwan | 3 | $99 |
Investigators on these documents
FEI number 3002806677 · most recent document Apr 12, 2024
About Chunghwa Chemical Synthesis & Biotech Co., Ltd.
How many FDA Form 483s has Chunghwa Chemical Synthesis & Biotech Co., Ltd. received?
FDA Intel has 2 Form 483s on file for Chunghwa Chemical Synthesis & Biotech Co., Ltd.; the most recent is dated Apr 12, 2024.
When was Chunghwa Chemical Synthesis & Biotech Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Chunghwa Chemical Synthesis & Biotech Co., Ltd. is a Form 483 dated Apr 12, 2024, for the site in New Taipei City, Taiwan.
What did FDA cite at Chunghwa Chemical Synthesis & Biotech Co., Ltd.?
The regulations cited most in the observations on file for Chunghwa Chemical Synthesis & Biotech Co., Ltd. are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.