Rentschler Biopharma Inc.
Form 483 issued March 22, 2023 · Milford, Massachusetts
- Inspection
- Mar 15 – Mar 22, 2023
- Investigators
- Leiyun Boone· Wendy G. Tan· Yuan-Chia Kuo
- Observations
- 6
- Pages
- 5
- FEI number
- 3003282293
In short: On March 22, 2023, FDA issued a Form 483 with 6 observations to Rentschler Biopharma Inc. in Milford, Massachusetts (FEI 3003282293) after an inspection that ran Mar 15 – Mar 22, 2023. The investigators were Leiyun Boone, Wendy G. Tan and Yuan-Chia Kuo. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 4 of 6 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
Procedures to prevent microbial…
- 02
Transfer, translation, transcription, and recording of data during manufacturing processes and QC testing do not always…
- 03
There is a lack of written procedures, or that written procedures are inadequate, or…
- 04
Deviation/Events management is not adequate and performed…
This inspection in context
Leiyun Boone
8 documents · 2021–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Germany.
The firmRentschler Biopharma Inc. history
All 3 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 Inc.?
FDA listed 6 observations on this Form 483, mostly about production, quality system 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 Inc.?
Leiyun Boone, Wendy G. Tan and Yuan-Chia Kuo are named on this Form 483, for the inspection of Mar 15 – Mar 22, 2023. Each investigator has a profile showing what they cite most.
When was Rentschler Biopharma Inc. inspected by FDA?
The inspection ran Mar 15 – Mar 22, 2023, and the Form 483 is dated March 22, 2023.
How do I get the full Form 483 for Rentschler Biopharma Inc.?
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.