Rentschler Biopharma SE
FDA inspection history in Laupheim, Germany, 2022 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2022: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–23Two Form 483s, at Laupheim, Germany.
- 2022The longest 483 on file: 9 observations over 5 pages at Laupheim, Germany.
Cited most
Across all Rentschler Biopharma SE observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.160General requirements2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Rentschler Biopharma SE file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Laupheim, Germany
Two Form 483s · 2022 to 2023 · 14 observations
Latest: Form 483, Mar 7, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-03-07 | 483 Form 483 | Laupheim, Germany | 5 | $99 |
| 2022-02-15 | 483 Form 483 | Laupheim, Germany | 9 | $99 |
Investigators on these documents
Caryn M. McNab (1)Jose E. Melendez (1)Leiyun Boone (1)Ralph M. Bernstein (1)Wayne Seifert (1)Wendy G. Tan (1)
FEI number 1000291122 · most recent document Mar 7, 2023
About Rentschler Biopharma SE
How many FDA Form 483s has Rentschler Biopharma SE received?
FDA Intel has 2 Form 483s on file for Rentschler Biopharma SE; the most recent is dated Mar 7, 2023.
When was Rentschler Biopharma SE last inspected by FDA?
The most recent FDA inspection document on file for Rentschler Biopharma SE is a Form 483 dated Mar 7, 2023, for the site in Laupheim, Germany.
What did FDA cite at Rentschler Biopharma SE?
The regulations cited most in the observations on file for Rentschler Biopharma SE are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time.