Rentschler Biopharma Inc.
Form 483 issued December 13, 2019 · Milford, Massachusetts
- Inspection
- Dec 4 – Dec 13, 2019
- Investigators
- Debra M. Emerson· Janet L. Bowen
- Observations
- 9
- Pages
- 4
- FEI number
- 3003282293
In short: On December 13, 2019, FDA issued a Form 483 with 9 observations to Rentschler Biopharma Inc. in Milford, Massachusetts (FEI 3003282293) after an inspection that ran Dec 4 – Dec 13, 2019. The investigators were Debra M. Emerson and Janet L. Bowen. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly…
- 02
Batch production and control records for(b)(4) drug substance do not include complete…
- 03
Laboratory methods are not established and followed to ensure that drug substance conforms to…
- 04
Insufficient controls have been established for the issuance and use of documents that are used…
This inspection in context
Debra M. Emerson
27 documents · 2008–2022
Cites 211.113 (control of microbiological contamination) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Rentschler Biopharma Inc.?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Rentschler Biopharma Inc.?
Debra M. Emerson and Janet L. Bowen are named on this Form 483, for the inspection of Dec 4 – Dec 13, 2019. Each investigator has a profile showing what they cite most.
When was Rentschler Biopharma Inc. inspected by FDA?
The inspection ran Dec 4 – Dec 13, 2019, and the Form 483 is dated December 13, 2019.
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.