Tubilux Pharma SPA
Form 483 issued December 10, 2019 · POMEZIA, Italy
- Inspection
- Dec 2 – Dec 10, 2019
- Investigators
- Dennis Cantellops· Melanie M. Walker
- Observations
- 4
- Pages
- 5
- FEI number
- 3003854110
In short: On December 10, 2019, FDA issued a Form 483 with 4 observations to Tubilux Pharma SPA in POMEZIA, Italy (FEI 3003854110) after an inspection that ran Dec 2 – Dec 10, 2019. The investigators were Dennis Cantellops and Melanie M. Walker. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
3 of 4 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(Laboratory System) Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
(Quality System) Procedures describing the handling of written and oral complaints related to drug products are…
- 03
(Quality System) The responsibilities and procedures applicable to the quality control unit…
- 04
(Quality System) The quality control unit lacks authority to fully investigate…
This inspection in context
Dennis Cantellops
10 documents · 2015–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmTubilux Pharma SPA history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tubilux Pharma SPA?
FDA listed 4 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Tubilux Pharma SPA?
Dennis Cantellops and Melanie M. Walker are named on this Form 483, for the inspection of Dec 2 – Dec 10, 2019. Each investigator has a profile showing what they cite most.
When was Tubilux Pharma SPA inspected by FDA?
The inspection ran Dec 2 – Dec 10, 2019, and the Form 483 is dated December 10, 2019.
How do I get the full Form 483 for Tubilux Pharma 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.