Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2019-03-15.
At a glance
Inspections
4
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 12 Mar 2019 – 15 Mar 2019 | Human Drugs | Clean | |
| 31 Aug 2010 | Not recorded | 483 | View 483 → |
| 23 Oct 2008 | Not recorded | Clean | |
| 18 Jan 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Aug 2010
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Robert J Martin, Suzanne M Healy, Margaret E Walsh
31 Aug 2010
21 CFR 211.25(b)
Supervisor Training/Education/Experience
Cited by Robert J Martin, Suzanne M Healy, Margaret E Walsh
31 Aug 2010
21 CFR 211.67(b)
Written procedures fail to include
Cited by Robert J Martin, Suzanne M Healy, Margaret E Walsh
31 Aug 2010
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Robert J Martin, Suzanne M Healy, Margaret E Walsh
31 Aug 2010
21 CFR 211.160(a)
Following/documenting laboratory controls
Cited by Robert J Martin, Suzanne M Healy, Margaret E Walsh
Investigators
FDA investigators tied to this site in the record.
Victoria M Daddeo1 insp.
Robert J Martin1 insp.
Suzanne M Healy1 insp.
Margaret E Walsh1 insp.
Mark R Mcclain1 insp.
Laurie B Frazier1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Collegium Pharmaceutical, Inc's 1 Form 483
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