Merck Serono SPA
Form 483 issued May 10, 2023 · Bari, Italy
- Inspection
- May 2 – May 10, 2023
- Investigator
- Richard Ledwidge
- Observations
- 5
- Pages
- 2
- FEI number
- 3003581732
In short: On May 10, 2023, FDA issued a Form 483 with 5 observations to Merck Serono SPA in Bari, Italy (FEI 3003581732) after an inspection that ran May 2 – May 10, 2023. The investigator was Richard Ledwidge. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The design of the ling machine: S | °Sauring fill Ime setup that has potential…
- 02
Control strategies regarding product…
- 03
Sterilization of | is…
- 04
Equipment Maintenance used in the cleaning and sterilization of drug product…
This inspection in context
Richard Ledwidge
18 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 firmMerck Serono SPA history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Merck Serono SPA?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, materials and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Merck Serono SPA?
Richard Ledwidge is named on this Form 483, for the inspection of May 2 – May 10, 2023. Each investigator has a profile showing what they cite most.
When was Merck Serono SPA inspected by FDA?
The inspection ran May 2 – May 10, 2023, and the Form 483 is dated May 10, 2023.
How do I get the full Form 483 for Merck Serono 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.