Rentschler Biopharma Inc.
FDA inspection history in Milford, Massachusetts, 2019 to 2025
- 3
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2023: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Milford, Massachusetts.
- 2019The longest 483 on file: 9 observations over 4 pages at Milford, Massachusetts.
- 2023–25Two Form 483s, at Milford, Massachusetts.
Cited most
Across all Rentschler Biopharma observations on file
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.160General requirements2
- 21 CFR 211.188Batch production and control records2
The complete Rentschler Biopharma file.
All 3 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
Milford, Massachusetts
Three Form 483s · 2019 to 2025 · 20 observations
Latest: Form 483, Jan 17, 2025 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-01-17 | 483 Form 483 | Milford, Massachusetts | 5 | $99 |
| 2023-03-22 | 483 Form 483 | Milford, Massachusetts | 6 | $99 |
| 2019-12-13 | 483 Form 483 | Milford, Massachusetts | 9 | $99 |
Investigators on these documents
Daniel L. Zheng (1)Debra M. Emerson (1)Divek R. Jumani (1)Janet L. Bowen (1)Leiyun Boone (1)Sean R. Marcsisin (1)Wendy G. Tan (1)Yuan-Chia Kuo (1)
FEI number 3003282293 · most recent document Jan 17, 2025
About Rentschler Biopharma Inc.
How many FDA Form 483s has Rentschler Biopharma Inc. received?
FDA Intel has 3 Form 483s on file for Rentschler Biopharma Inc.; the most recent is dated Jan 17, 2025.
When was Rentschler Biopharma Inc. last inspected by FDA?
The most recent FDA inspection document on file for Rentschler Biopharma Inc. is a Form 483 dated Jan 17, 2025, for the site in Milford, Massachusetts.
What did FDA cite at Rentschler Biopharma Inc.?
The regulations cited most in the observations on file for Rentschler Biopharma Inc. are 21 CFR 211.100 (Written procedures; deviations), 3 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 3 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times.