Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-28.
At a glance
Inspections
7
Form 483s
6
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Feb 2025 – 28 Feb 2025 | Human Drugs | 483 | View 483 → |
| 8 Sep 2021 – 21 Sep 2021 | Human Drugs | 483 | View 483 → |
| 17 Jan 2019 – 30 Jan 2019 | Human Drugs | 483 | View 483 → |
| 27 Feb 2017 – 2 Mar 2017 | Foods & Cosmetics | 483 | View 483 → |
| 14 Apr 2014 – 23 Apr 2014 | Human Drugs | 483 | View 483 → |
| 10 May 2012 | Not recorded | 483 | View 483 → |
| 15 Jul 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Feb 2025
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Joanne E King, Mickell Smith
28 Feb 2025
21 CFR 211.186(b)(9)
Complete instructions, procedures, specifications et. al.
Cited by Joanne E King, Mickell Smith
28 Feb 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Joanne E King, Mickell Smith
Investigators
FDA investigators tied to this site in the record.
Joanne E King2 insp.
Jennifer Lalama2 insp.
Mickell Smith1 insp.
Teresa I Navas1 insp.
Rozelle G Smith1 insp.
Richard A Lyght1 insp.
Ileana Barreto-Pettit1 insp.
Stacey F Rivette1 insp.
German Rivera1 insp.
Raymond A Lyn1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.111 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.188(b)(10) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.12(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.25(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.320(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.320(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.365(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind this site's 6 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