Chunghwa Chemical Synthesis & Biotech Co., Ltd.
Form 483 issued April 12, 2024 · New Taipei City, Taiwan
- Investigator
- Robert J. Ham
- Observations
- 3
- Pages
- 2
- FEI number
- 3002806677
In short: On April 12, 2024, FDA issued a Form 483 with 3 observations to Chunghwa Chemical Synthesis & Biotech Co., Ltd. in New Taipei City, Taiwan (FEI 3002806677). The investigator was Robert J. Ham. Most observations concern quality system and production.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to establish written procedures to monitor the progress and control the performance of processing steps…
- 02
Written records of investigations are not established and followed for inv estigating critical deviations or the…
- 03
The responsibilities and procedures applicable to the quality unit are not in…
This inspection in context
Robert J. Ham
32 documents · 2012–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Missouri.
The firmChunghwa Chemical Synthesis & Biotech Co., Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Chunghwa Chemical Synthesis & Biotech Co., Ltd.?
FDA listed 3 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
Who inspected Chunghwa Chemical Synthesis & Biotech Co., Ltd.?
Robert J. Ham is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Chunghwa Chemical Synthesis & Biotech Co., Ltd. inspected by FDA?
This Form 483 is dated April 12, 2024.
How do I get the full Form 483 for Chunghwa Chemical Synthesis & Biotech Co., Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.