Rentschler Biopharma SE
Form 483 issued March 7, 2023 · Laupheim, Germany
- Inspection
- Feb 27 – Mar 7, 2023
- Investigators
- Caryn M. McNab· Leiyun Boone· Wendy G. Tan
- Observations
- 5
- Pages
- 3
- FEI number
- 1000291122
In short: On March 7, 2023, FDA issued a Form 483 with 5 observations to Rentschler Biopharma SE in Laupheim, Germany (FEI 1000291122) after an inspection that ran Feb 27 – Mar 7, 2023. The investigators were Caryn M. McNab, Leiyun Boone and Wendy G. Tan. Most observations concern production and laboratory controls.
At a glance
Observations span 3 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures to prevent microbial…
- 02
Environmental monitoring culture plates are placed in closed boxes in the incubators at (b)(4) C and…
- 03
Responsibilities of the quality unit are…
- 04
The cell bank transport system for internal transfer of (b)(4) cell…
This inspection in context
Caryn M. McNab
7 documents · 2013–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmRentschler Biopharma SE history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Rentschler Biopharma SE?
FDA listed 5 observations on this Form 483, mostly about production, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Rentschler Biopharma SE?
Caryn M. McNab, Leiyun Boone and Wendy G. Tan are named on this Form 483, for the inspection of Feb 27 – Mar 7, 2023. Each investigator has a profile showing what they cite most.
When was Rentschler Biopharma SE inspected by FDA?
The inspection ran Feb 27 – Mar 7, 2023, and the Form 483 is dated March 7, 2023.
How do I get the full Form 483 for Rentschler Biopharma SE?
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.