Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-25.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Mar 2025 – 25 Mar 2025 | Human Drugs | WL | View 483 → |
| 25 Aug 2020 – 4 Sep 2020 | Human Drugs | 483 | View 483 → |
| 7 Mar 2012 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Mar 2025
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Jeffrey P Raimondi, Thuy Tram L Nguyen, Aranjeet Singh
25 Mar 2025
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Jeffrey P Raimondi, Thuy Tram L Nguyen, Aranjeet Singh
25 Mar 2025
21 CFR 211.166(a)
Lack of written stability program
Cited by Jeffrey P Raimondi, Thuy Tram L Nguyen, Aranjeet Singh
25 Mar 2025
21 CFR 211.182
Written records kept in individual logs
Cited by Jeffrey P Raimondi, Thuy Tram L Nguyen, Aranjeet Singh
25 Mar 2025
21 CFR 211.192
No written record of investigation
Cited by Jeffrey P Raimondi, Thuy Tram L Nguyen, Aranjeet Singh
Investigators
FDA investigators tied to this site in the record.
Jeffrey P Raimondi1 insp.
Thuy Tram L Nguyen1 insp.
Aranjeet Singh1 insp.
Stephanie A Slater1 insp.
Durell L Giles1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.125(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.182 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Creative Essences Inc'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