Bushu Pharmaceuticals Ltd.
Form 483 issued December 2, 2022 · Kawagoe, Japan
- Inspection
- Nov 28 – Dec 2, 2022
- Investigator
- Noreen Muniz
- Observations
- 3
- Pages
- 4
- FEI number
- 3005709762
In short: On December 2, 2022, FDA issued a Form 483 with 3 observations to Bushu Pharmaceuticals Ltd. in Kawagoe, Saitama (FEI 3005709762) after an inspection that ran Nov 28 – Dec 2, 2022. The investigator was Noreen Muniz. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Established test procedures and laboratory control mechanisms are not followed and documented at…
- 03
The separate or defined areas and control systems necessary to prevent contamination…
This inspection in context
Noreen Muniz
24 documents · 2008–2022
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmBushu Pharmaceuticals Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bushu Pharmaceuticals Ltd.?
FDA listed 3 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Bushu Pharmaceuticals Ltd.?
Noreen Muniz is named on this Form 483, for the inspection of Nov 28 – Dec 2, 2022. Each investigator has a profile showing what they cite most.
When was Bushu Pharmaceuticals Ltd. inspected by FDA?
The inspection ran Nov 28 – Dec 2, 2022, and the Form 483 is dated December 2, 2022.
How do I get the full Form 483 for Bushu Pharmaceuticals 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.