FDA Form 483 Takeda Manufacturing, Singapore, Nov 2022
Form 483 issued November 18, 2022
- Inspection
- Nov 10 – Nov 18, 2022
- Investigators
- Prabhu P. Raju· Zuben Sauna
- Observations
- 2
- Pages
- 3
- FEI number
- 300915365
In short: On November 18, 2022, FDA issued a Form 483 with 2 observations to FDA Form 483 Takeda Manufacturing, Singapore, Nov 2022 (FEI 300915365) after an inspection that ran Nov 10 – Nov 18, 2022. The investigators were Prabhu P. Raju and Zuben Sauna. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies do not always include all the…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Prabhu P. Raju
21 documents · 2008–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in France.
The firmFDA Form 483 Takeda Manufacturing, Singapore, Nov 2022 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at FDA Form 483 Takeda Manufacturing, Singapore, Nov 2022?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected FDA Form 483 Takeda Manufacturing, Singapore, Nov 2022?
Prabhu P. Raju and Zuben Sauna are named on this Form 483, for the inspection of Nov 10 – Nov 18, 2022. Each investigator has a profile showing what they cite most.
When was FDA Form 483 Takeda Manufacturing, Singapore, Nov 2022 inspected by FDA?
The inspection ran Nov 10 – Nov 18, 2022, and the Form 483 is dated November 18, 2022.
How do I get the full Form 483 for FDA Form 483 Takeda Manufacturing, Singapore, Nov 2022?
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.