Form 483 · FEI 3010600159
Form 483 issued December 6, 2022 · Lingolsheim, France
- Inspection
- Nov 28 – Dec 6, 2022
- Investigators
- Malgorzata G. Norton· Roger F. Zabinski
- Observations
- 10
- Pages
- 8
- FEI number
- 3010600159
In short: On December 6, 2022, FDA issued a Form 483 with 10 observations to an FDA-inspected site in Lingolsheim, France (FEI 3010600159) after an inspection that ran Nov 28 – Dec 6, 2022. The investigators were Malgorzata G. Norton and Roger F. Zabinski. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 6 of 10 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Discrepancies are not thoroughly assessed for product impact. There is a failure to thoroughly review any…
- 02
Written production and process control procedures are not followed, recorded, and justified in the execution of…
- 03
Components for drug product manufacturing are not measured…
- 04
There is no assurance that employees engaged in the manufacture, processing and holding of a drug…
This inspection in context
Malgorzata G. Norton
3 documents · 2018–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmSite 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 an FDA-inspected site?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Malgorzata G. Norton and Roger F. Zabinski are named on this Form 483, for the inspection of Nov 28 – Dec 6, 2022. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Nov 28 – Dec 6, 2022, and the Form 483 is dated December 6, 2022.
How do I get the full Form 483 for an FDA-inspected site?
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.