Takeda Manufacturing Italia SPA
Form 483 issued November 12, 2024 · Cittaducale, Italy
- Inspection
- Nov 4 – Nov 12, 2024
- Investigators
- Alan L. Truong· Shafig Ahadi
- Observations
- 3
- Pages
- 3
- FEI number
- 3007244131
In short: On November 12, 2024, FDA issued a Form 483 with 3 observations to Takeda Manufacturing Italia SPA in Cittaducale, Italy (FEI 3007244131) after an inspection that ran Nov 4 – Nov 12, 2024. The investigators were Alan L. Truong and Shafig Ahadi. Most observations concern production and quality system.
At a glance
Production and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The batch production and control records are deficient in that they do not include…
- 02
Written production and process control procedures…
- 03
Equipment and utensils are not cleaned, maintained, and sanitized appropriately to prevent contamination and malfunctions that…
This inspection in context
Alan L. Truong
16 documents · 2019–2025
Cites 211.188 (batch production and control records) more than any other section. Most of their documents are for sites in California.
The firmTakeda Manufacturing Italia SPA history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.188
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Takeda Manufacturing Italia SPA?
FDA listed 3 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Takeda Manufacturing Italia SPA?
Alan L. Truong and Shafig Ahadi are named on this Form 483, for the inspection of Nov 4 – Nov 12, 2024. Each investigator has a profile showing what they cite most.
When was Takeda Manufacturing Italia SPA inspected by FDA?
The inspection ran Nov 4 – Nov 12, 2024, and the Form 483 is dated November 12, 2024.
How do I get the full Form 483 for Takeda Manufacturing Italia SPA?
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.