TTY Biopharm Company Limited Lioudu Factory
Form 483 issued August 30, 2022 · Keelung City, Taiwan
- Inspection
- Aug 22 – Aug 30, 2022
- Investigator
- Kham Phommachanh
- Observations
- 4
- Pages
- 2
- FEI number
- 3015497585
In short: On August 30, 2022, FDA issued a Form 483 with 4 observations to TTY Biopharm Company Limited Lioudu Factory in Keelung City, Taiwan (FEI 3015497585) after an inspection that ran Aug 22 – Aug 30, 2022. The investigator was Kham Phommachanh. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Reserve drug product samples are not retained and stored under conditions…
- 02
Deviations from written test procedures and laboratory mechanisms are…
- 03
Employees are not given training in current good manufacturing practices and written procedures required by current…
- 04
Washing and toilet facilities lack…
This inspection in context
Kham Phommachanh
12 documents · 2009–2024
Cites 211.194 (laboratory records) more than any other section. Most of their documents are for sites in Canada.
The firmTTY Biopharm Company Limited Lioudu Factory history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.170
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at TTY Biopharm Company Limited Lioudu Factory?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected TTY Biopharm Company Limited Lioudu Factory?
Kham Phommachanh is named on this Form 483, for the inspection of Aug 22 – Aug 30, 2022. Each investigator has a profile showing what they cite most.
When was TTY Biopharm Company Limited Lioudu Factory inspected by FDA?
The inspection ran Aug 22 – Aug 30, 2022, and the Form 483 is dated August 30, 2022.
How do I get the full Form 483 for TTY Biopharm Company Limited Lioudu Factory?
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.