Taiwan Biotech Co, Ltd
Form 483 issued September 20, 2022 · Taoyuan City, Taiwan
- Inspection
- Sep 12 – Sep 20, 2022
- Investigator
- Wayne D. McGrath
- Observations
- 2
- Pages
- 4
- FEI number
- 3003598505
In short: On September 20, 2022, FDA issued a Form 483 with 2 observations to Taiwan Biotech Co, Ltd in Taoyuan City, Taiwan (FEI 3003598505) after an inspection that ran Sep 12 – Sep 20, 2022. The investigator was Wayne D. McGrath. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Results of stability testing are not used in determining appropriate storage…
This inspection in context
Wayne D. McGrath
33 documents · 2018–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmTaiwan Biotech Co, Ltd history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Taiwan Biotech Co, Ltd?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Taiwan Biotech Co, Ltd?
Wayne D. McGrath is named on this Form 483, for the inspection of Sep 12 – Sep 20, 2022. Each investigator has a profile showing what they cite most.
When was Taiwan Biotech Co, Ltd inspected by FDA?
The inspection ran Sep 12 – Sep 20, 2022, and the Form 483 is dated September 20, 2022.
How do I get the full Form 483 for Taiwan 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.