Rentschler Biopharma Inc.
Form 483 issued January 17, 2025 · Milford, Massachusetts
- Inspection
- Jan 7 – Jan 17, 2025
- Investigators
- Daniel L. Zheng· Divek R. Jumani· Sean R. Marcsisin
- Observations
- 5
- Pages
- 5
- FEI number
- 3003282293
In short: On January 17, 2025, FDA issued a Form 483 with 5 observations to Rentschler Biopharma Inc. in Milford, Massachusetts (FEI 3003282293) after an inspection that ran Jan 7 – Jan 17, 2025. The investigators were Daniel L. Zheng, Divek R. Jumani and Sean R. Marcsisin. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and production account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data…
- 02
Failure to establish adequate written procedures for cleaning equipment and its release for use…
- 03
Procedures to prevent microbial…
- 04
Failure to record all quality-related activities at the…
This inspection in context
Daniel L. Zheng
24 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
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 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Rentschler Biopharma Inc.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Rentschler Biopharma Inc.?
Daniel L. Zheng, Divek R. Jumani and Sean R. Marcsisin are named on this Form 483, for the inspection of Jan 7 – Jan 17, 2025. Each investigator has a profile showing what they cite most.
When was Rentschler Biopharma Inc. inspected by FDA?
The inspection ran Jan 7 – Jan 17, 2025, and the Form 483 is dated January 17, 2025.
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.