Rentschler Biopharma SE
Form 483 issued February 15, 2022 · Laupheim, Germany
- Inspection
- Feb 7 – Feb 15, 2022
- Investigators
- Jose E. Melendez· Ralph M. Bernstein· Wayne Seifert
- Observations
- 9
- Pages
- 5
- FEI number
- 1000291122
In short: On February 15, 2022, FDA issued a Form 483 with 9 observations to Rentschler Biopharma SE in Laupheim, Germany (FEI 1000291122) after an inspection that ran Feb 7 – Feb 15, 2022. The investigators were Jose E. Melendez, Ralph M. Bernstein and Wayne Seifert. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and facilities & equipment account for 6 of 9 observations.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
On February 1, 2022, we (WS and JM) observed the simulated fill process (b)(4) simulation of…
- 02
Cleaned and pending use (b)(4) and (b)(4) have rings of discoloration below the top of the…
- 03
Laboratory procedures or testing to assure compliance with established specifications and…
- 04
The drug substance excipient…
This inspection in context
Jose E. Melendez
44 documents · 2001–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Rentschler Biopharma SE?
FDA listed 9 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Rentschler Biopharma SE?
Jose E. Melendez, Ralph M. Bernstein and Wayne Seifert are named on this Form 483, for the inspection of Feb 7 – Feb 15, 2022. Each investigator has a profile showing what they cite most.
When was Rentschler Biopharma SE inspected by FDA?
The inspection ran Feb 7 – Feb 15, 2022, and the Form 483 is dated February 15, 2022.
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.