Chugai Pharma Manufacturing Co. Ltd. (CPMC)
Form 483 issued August 23, 2021 · TKY, Japan
- Observations
- 6
- Pages
- 3
- FEI number
- 3004109596
In short: On August 23, 2021, FDA issued a Form 483 with 6 observations to Chugai Pharma Manufacturing Co. Ltd. (CPMC) in TKY, Japan (FEI 3004109596). Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.56 (sanitation).
At a glance
Facilities & equipment and production account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a lack of assurance that your cleaning procedures, used for product-contact process equipment used…
- 02
Your firm has not established adequate procedural controls to protec; ic data acquisition systems used for…
- 03
Standard Operating procedures or work instructions are not…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Questions about this 483
What did FDA find at Chugai Pharma Manufacturing Co. Ltd. (CPMC)?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.56 (sanitation). The opening words of each observation are shown on this page.
When was Chugai Pharma Manufacturing Co. Ltd. (CPMC) inspected by FDA?
This Form 483 is dated August 23, 2021.
How do I get the full Form 483 for Chugai Pharma Manufacturing Co. Ltd. (CPMC)?
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.