Overview
- 7 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-02-23.
At a glance
Inspections
7
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Feb 2024 – 23 Feb 2024 | Human Drugs | 483 | View 483 → |
| 29 Aug 2022 – 31 Aug 2022 | Foods & Cosmetics | 483 | View 483 → |
| 2 Sep 2016 – 16 Sep 2016 | Foods & Cosmetics | 483 | On file |
| 1 Mar 2012 | Not recorded | 483 | View 483 → |
| 14 Feb 2011 | Not recorded | WL | View 483 → |
| 7 Jun 2007 | Not recorded | Clean | |
| 15 Jun 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Feb 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Angelica M Hernandez, Megan T Ziegler
23 Feb 2024
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Angelica M Hernandez, Megan T Ziegler
23 Feb 2024
21 CFR 211.63
Equipment Design, Size and Location
Cited by Angelica M Hernandez, Megan T Ziegler
23 Feb 2024
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Angelica M Hernandez, Megan T Ziegler
31 Aug 2022
21 CFR 111.103
Written procedures - quality control operations
Cited by Ivis L Negron Torres, Benita C Okeke
Investigators
FDA investigators tied to this site in the record.
Ileana Barreto-Pettit2 insp.
Angelica M Hernandez1 insp.
Megan T Ziegler1 insp.
Ivis L Negron Torres1 insp.
Benita C Okeke1 insp.
Omayra N Rodriguez-Ruiz1 insp.
Aaron F Coleman1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.430(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.12(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.180(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.503 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.83(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.12 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.14(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.160(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.180(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.30(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.35(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.101(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(d) | 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 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.184(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.188(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | 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 Miramar Cosmetics, Inc DBA Miramar Lab's 5 Form 483s
Source PDFs, 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