YUNG SHIN PHARM. IND. CO., LTD. (TAICHUNG YOUTH FACTORY)
Form 483 issued October 22, 2019 · Taichung City, Taiwan
- Inspection
- Oct 14 – Oct 22, 2019
- Investigator
- Bijoy Panicker
- Observations
- 7
- Pages
- 5
- FEI number
- 3002808536
In short: On October 22, 2019, FDA issued a Form 483 with 7 observations to YUNG SHIN PHARM. IND. CO., LTD. (TAICHUNG YOUTH FACTORY) in Taichung City, Taiwan (FEI 3002808536) after an inspection that ran Oct 14 – Oct 22, 2019. The investigator was Bijoy Panicker. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established which monitor the output of those manufacturing processes that may be…
- 02
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room…
This inspection in context
Bijoy Panicker
34 documents · 2017–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmYUNG SHIN PHARM. IND. CO., LTD. (TAICHUNG YOUTH FACTORY) history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at YUNG SHIN PHARM. IND. CO., LTD. (TAICHUNG YOUTH FACTORY)?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected YUNG SHIN PHARM. IND. CO., LTD. (TAICHUNG YOUTH FACTORY)?
Bijoy Panicker is named on this Form 483, for the inspection of Oct 14 – Oct 22, 2019. Each investigator has a profile showing what they cite most.
When was YUNG SHIN PHARM. IND. CO., LTD. (TAICHUNG YOUTH FACTORY) inspected by FDA?
The inspection ran Oct 14 – Oct 22, 2019, and the Form 483 is dated October 22, 2019.
How do I get the full Form 483 for YUNG SHIN PHARM. IND. CO., LTD. (TAICHUNG YOUTH 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.