Chunghwa Chemical Synthesis & Biotech Co., Ltd.
Form 483 issued November 18, 2022 · New Taipei City, Taiwan
- Investigators
- Matthew B. Casale· Wen Ning Chan
- Observations
- 3
- Pages
- 1
- FEI number
- 3002806677
In short: On November 18, 2022, FDA issued a Form 483 with 3 observations to Chunghwa Chemical Synthesis & Biotech Co., Ltd. in New Taipei City, Taiwan (FEI 3002806677). The investigators were Matthew B. Casale and Wen Ning Chan. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 3 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×) · 211.87 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
There has been no requirement to review electronic raw data in the chromatography system for any…
- 03
The retest date for T<"> the key starting material for the…
This inspection in context
Matthew B. Casale
29 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
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 211.192
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 materials. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Chunghwa Chemical Synthesis & Biotech Co., Ltd.?
Matthew B. Casale and Wen Ning Chan are 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 November 18, 2022.
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.