Brammer Bio MA, LLC
Form 483 issued August 30, 2023 · Cambridge, Massachusetts
- Inspection
- Aug 23 – Aug 30, 2023
- Investigators
- Lewis K. Antwi· Thai D. Truong
- Observations
- 2
- Pages
- 4
- FEI number
- 3013417996
In short: On August 30, 2023, FDA issued a Form 483 with 2 observations to Brammer Bio MA, LLC in Cambridge, Massachusetts (FEI 3013417996) after an inspection that ran Aug 23 – Aug 30, 2023. The investigators were Lewis K. Antwi and Thai D. Truong. Most observations concern facilities & equipment.
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Inadequate space for the orderly placement of raw materials/ manufacturing supplies in your holding dock staging…
This inspection in context
Lewis K. Antwi
11 documents · 2019–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
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 211.58
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Brammer Bio MA, LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Brammer Bio MA, LLC?
Lewis K. Antwi and Thai D. Truong are named on this Form 483, for the inspection of Aug 23 – Aug 30, 2023. Each investigator has a profile showing what they cite most.
When was Brammer Bio MA, LLC inspected by FDA?
The inspection ran Aug 23 – Aug 30, 2023, and the Form 483 is dated August 30, 2023.
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.