Brammer Bio MA, LLC
Form 483 issued February 10, 2021 · Cambridge, Massachusetts
- Inspection
- Feb 1 – Feb 10, 2021
- Investigators
- Lauren M. Lilly· Scott Ballard
- Observations
- 3
- Pages
- 4
- FEI number
- 3013417996
In short: On February 10, 2021, FDA issued a Form 483 with 3 observations to Brammer Bio MA, LLC in Cambridge, Massachusetts (FEI 3013417996) after an inspection that ran Feb 1 – Feb 10, 2021. The investigators were Lauren M. Lilly and Scott Ballard. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 2 of 3 observations.
Most cited: 21 CFR 211.42 (1×) · 211.25 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and Facilities are not designed to…
- 02
Employees are not adequately trained in the particular operations…
- 03
Production records are not controlled in a way that minimizes the risk of damage…
This inspection in context
Lauren M. Lilly
5 documents · 2020–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmBrammer Bio MA, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Brammer Bio MA, LLC?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Brammer Bio MA, LLC?
Lauren M. Lilly and Scott Ballard are named on this Form 483, for the inspection of Feb 1 – Feb 10, 2021. Each investigator has a profile showing what they cite most.
When was Brammer Bio MA, LLC inspected by FDA?
The inspection ran Feb 1 – Feb 10, 2021, and the Form 483 is dated February 10, 2021.
How do I get the full Form 483 for Brammer Bio MA, LLC?
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.