Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-08-13.
At a glance
Inspections
7
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Jul 2024 – 13 Aug 2024 | Foods & Cosmetics | 483 | View 483 → |
| 2 Aug 2022 – 8 Aug 2022 | Foods & Cosmetics | Clean | |
| 7 Aug 2018 – 16 Aug 2018 | Foods & Cosmetics | 483 | View 483 → |
| 3 Sep 2014 – 10 Sep 2014 | Foods & Cosmetics | 483 | On file |
| 14 May 2013 – 24 May 2013 | Human Drugs | 483 | View 483 → |
| 6 Jul 2012 | Not recorded | 483 | View 483 → |
| 1 Aug 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Aug 2024
21 CFR 111.205(a)
Master manufacturing record - prepared
Cited by Benita C Okeke, Siobhan G Taylor, Karissa J Mccaw
13 Aug 2024
21 CFR 111.210
Master manufacturing record - record requirements
Cited by Benita C Okeke, Siobhan G Taylor, Karissa J Mccaw
13 Aug 2024
21 CFR 111.315(d)
Standard reference materials; criteria for selecting
Cited by Benita C Okeke, Siobhan G Taylor, Karissa J Mccaw
13 Aug 2024
21 CFR 111.315(e)
Examination, testing; established criteria
Cited by Benita C Okeke, Siobhan G Taylor, Karissa J Mccaw
13 Aug 2024
21 CFR 111.320(b)
Examination, testing; scientifically valid
Cited by Benita C Okeke, Siobhan G Taylor, Karissa J Mccaw
Investigators
FDA investigators tied to this site in the record.
Meredith M Cobb2 insp.
Ashley Segura2 insp.
Benita C Okeke1 insp.
Siobhan G Taylor1 insp.
Karissa J Mccaw1 insp.
Marc Balzarini1 insp.
Lourdes Andujar1 insp.
Sharon Giamberini1 insp.
Haijing Hu1 insp.
Lizaida E Rodriguez1 insp.
Sandra Carpio1 insp.
Jessica L Pressley1 insp.
Ashley A Mutawakkil1 insp.
Ashley B Jelonek1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.570(b)(2)(ii)(F) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.455(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.10(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.12(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.127 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.13(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.130 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.135 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.14(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210 | 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(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.315(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.315(e) | 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 111.410(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.415(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.475(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.73 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(d)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(h)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Xymogen Manufacturing, LLC's 6 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