Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-12-21.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Dec 2022 – 21 Dec 2022 | Foods & Cosmetics | 483 | View 483 → |
| 28 Sep 2018 – 4 Oct 2018 | Foods & Cosmetics | Clean | |
| 3 Aug 2015 – 14 Aug 2015 | Human Drugs | 483 | View 483 → |
| 21 Jun 2013 – 8 Jul 2013 | Foods & Cosmetics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Dec 2022
21 CFR 111.205(b)(1)
Master manufacturing record-specifications; packaged, label
Cited by Narahi J Alvarez Alcazar
21 Dec 2022
21 CFR 111.205(b)(1)
Master manufacturing record-specifications; packaged, label
Cited by Narahi J Alvarez Alcazar
Investigators
FDA investigators tied to this site in the record.
Narahi J Alvarez Alcazar1 insp.
Thomas C Mclean1 insp.
Kimberly J Proctor Jones1 insp.
Jessica L Kocian1 insp.
Hugh Grimoldby1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 111.570(b)(1) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.153 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.205(b)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.503 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.205(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.260(k) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.65 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.430(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.535(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 3 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