Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-04-04.
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 |
|---|---|---|---|
| 26 Mar 2019 – 4 Apr 2019 | Foods & Cosmetics | 483 | View 483 → |
| 12 Mar 2018 – 16 Mar 2018 | Foods & Cosmetics | 483 | View 483 → |
| 3 Apr 2017 – 7 Apr 2017 | Foods & Cosmetics | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
4 Apr 2019
21 CFR 111.15(b)(1)
Physical plant - clean and sanitary
Cited by Sondra L Phillips, Andrea L Williams-Jones
4 Apr 2019
21 CFR 111.15(d)(2)
Pest control measures
Cited by Sondra L Phillips, Andrea L Williams-Jones
4 Apr 2019
21 CFR 111.205(b)(2)
Master manufacturing record - controls, procedures
Cited by Sondra L Phillips, Andrea L Williams-Jones
4 Apr 2019
21 CFR 111.20(f)
Physical plant - bulbs, fixtures, skylights
Cited by Sondra L Phillips, Andrea L Williams-Jones
4 Apr 2019
21 CFR 111.255(b)
Batch record - complete
Cited by Sondra L Phillips, Andrea L Williams-Jones
Investigators
FDA investigators tied to this site in the record.
Sondra L Phillips2 insp.
Andrea L Williams-Jones1 insp.
Alphonso A Haupt1 insp.
Robin N Goins1 insp.
Adam J Williams1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 111.70(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 111.15(b)(1) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.15(d)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.20(f) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.205(b)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.415(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.455(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.140(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.155(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.205(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.475(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.535(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.570(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.570(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.65 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.80(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.15(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.15(f)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(a)(3)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.465(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Nexagen, LLC's 3 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