Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2009-02-23.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Feb 2009 | Not recorded | 483 | View 483 → |
| 27 Jan 2009 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Feb 2009
21 CFR 211.115(a)
Reprocessing procedures not written or followed
Cited by Amy C Jordan, Richard H Penta
23 Feb 2009
21 CFR 211.194(a)
Complete test data included in records
Cited by Amy C Jordan, Richard H Penta
23 Feb 2009
21 CFR 211.194(a)(5)
Calculations performed are in the records
Cited by Amy C Jordan, Richard H Penta
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.115(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(5) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Acusphere, Incorporated's 2 Form 483s
Verbatim observations 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