Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-12-19.
At a glance
Inspections
2
Form 483s
2
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Dec 2023 – 19 Dec 2023 | Biologics | 483 | View 483 → |
| 1 Feb 2021 – 10 Feb 2021 | Biologics | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Dec 2023
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Karlton T Watson, Priscilla M Pastrana
Investigators
FDA investigators tied to this site in the record.
Karlton T Watson1 insp.
Priscilla M Pastrana1 insp.
Scott T Ballard1 insp.
Lauren M Lilly1 insp.
Steven E Bowen1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Brammer Bio MA, LLC's 2 Form 483s
Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat