Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-01-10.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Nov 2017 – 10 Jan 2018 | Human Drugs | 483 | View 483 → |
| 29 Apr 2015 – 26 May 2015 | Medical Devices & Rad Health | 483 | On file |
| 24 Mar 2014 – 16 May 2014 | Medical Devices & Rad Health | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Jan 2018
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Jessica M Monteiro, James R Birkenstamm, William J Muszynski
10 Jan 2018
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Jessica M Monteiro, James R Birkenstamm, William J Muszynski
10 Jan 2018
21 CFR 211.142(a)
Quarantine - actual practice
Cited by Jessica M Monteiro, James R Birkenstamm, William J Muszynski
10 Jan 2018
21 CFR 211.142(a)
Quarantine - actual practice
Cited by Jessica M Monteiro, James R Birkenstamm, William J Muszynski
10 Jan 2018
21 CFR 211.150(b)
Distribution Recall System
Cited by Jessica M Monteiro, James R Birkenstamm, William J Muszynski
Investigators
FDA investigators tied to this site in the record.
Jessica M Monteiro3 insp.
James R Birkenstamm1 insp.
William J Muszynski1 insp.
Jennifer L Custodio1 insp.
Nicholas A Violand1 insp.
Denise M Visco1 insp.
Edward Oshaughnessy1 insp.
Jonee J Mearns1 insp.
Doreen P Gubbay1 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 | 4x |
| 21 CFR 211.142(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.150(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.204 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 4x |
| n/a | Cited across public-safe Form 483 observations | 4x |
Full site report
Get the verbatim findings behind Flawless Beauty LLC's 3 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