Home / Companies / Chunghwa Chemical Synthesis & Biotech Co., Ltd

Chunghwa Chemical Synthesis & Biotech Co., Ltd FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection VAI · Apr 12, 2024
No warning letters matched by name

Inspections 7

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Chunghwa Chemical Synthesis & Biotech Co., Ltd has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Chunghwa Chemical Synthesis & Biotech Co., Ltd" is on file. FDA has published 1 Form 483 for Chunghwa Chemical Synthesis & Biotech Co., Ltd.

What these totals cover: FDA records filed under the name "Chunghwa Chemical Synthesis & Biotech Co., Ltd" and its spelling variant "Chunghwa Chemical Synthesis And Biotech Co".

Latest inspection: Apr 12, 2024 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	7	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Chunghwa Chemical Synthesis & Biotech Co., Ltd's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Chunghwa Chemical Synthesis & Biotech Co., Ltd: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	1	0	0	0	0
2023	0	0	0	0	0
2022	1	0	0	0	0
2021	1	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	1	0	0	0	0
2017	1	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Reviewing Chunghwa Chemical Synthesis & Biotech Co., Ltd as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Chunghwa Chemical Synthesis & Biotech Co., Ltd yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Chunghwa Chemical Synthesis & Biotech Co., Ltd Form 483s

1 Form 483 published by FDA.

Date	Document	FEI
Nov 18, 2022 · Document on fda.gov	483	3002806677

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

7 inspections from Apr 21, 2011 to Apr 12, 2024.

Date	Site	Product	Classification	FEI
Apr 12, 2024	New Taipei City, Taiwan	Drugs	Voluntary Action Indicated (VAI)	3002806677
Nov 18, 2022	New Taipei City, Taiwan	Drugs	Voluntary Action Indicated (VAI)	3002806677
Jun 21, 2021	New Taipei City, Taiwan	Drugs	Voluntary Action Indicated (VAI)	3002806677
Nov 9, 2018	New Taipei City, Taiwan	Drugs	Voluntary Action Indicated (VAI)	3002806677
Mar 29, 2017	New Taipei City, Taiwan	Drugs	No Action Indicated (NAI)	3002806677
May 20, 2014	New Taipei City, Taiwan	Drugs	No Action Indicated (NAI)	3002806677
Apr 21, 2011	New Taipei City, Taiwan	Drugs	Voluntary Action Indicated (VAI)	3002806677

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3002806677	New Taipei City, Taiwan	7	Apr 12, 2024

Chunghwa Chemical Synthesis & Biotech Co., Ltd and the FDA: common questions

Has Chunghwa Chemical Synthesis & Biotech Co., Ltd received an FDA warning letter?

No FDA warning letter addressed to the name "Chunghwa Chemical Synthesis & Biotech Co., Ltd" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Chunghwa Chemical Synthesis & Biotech Co., Ltd received an FDA Form 483?

FDA has published 1 Form 483 for Chunghwa Chemical Synthesis & Biotech Co., Ltd in its reading room, the most recent dated Nov 18, 2022. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Chunghwa Chemical Synthesis & Biotech Co., Ltd?

The most recent FDA inspection on file ended Apr 12, 2024 at New Taipei City, Taiwan and was classified VAI. FDA has 7 inspections of Chunghwa Chemical Synthesis & Biotech Co., Ltd on file.

Need more than this page shows? Ask about Chunghwa Chemical Synthesis & Biotech Co., Ltd in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.