Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-11-07.
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 |
|---|---|---|---|
| 16 Oct 2024 – 7 Nov 2024 | Foods & Cosmetics | 483 | View 483 → |
| 11 Mar 2024 – 21 Mar 2024 | Foods & Cosmetics | 483 | View 483 → |
| 11 Mar 2024 – 13 Mar 2024 | Foods & Cosmetics | Clean | |
| 5 Jan 2023 – 13 Jan 2023 | Foods & Cosmetics | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
7 Nov 2024
21 CFR 111.103
Written procedures - follow; quality control operations
Cited by Meaghan M Rabideau
7 Nov 2024
21 CFR 111.105(a)
Quality control - processes, specifications, written procedures
Cited by Meaghan M Rabideau
7 Nov 2024
21 CFR 111.113(b)(2)
Quality control - reject; specification not met
Cited by Meaghan M Rabideau
7 Nov 2024
21 CFR 111.210
Master manufacturing record - record requirements
Cited by Meaghan M Rabideau
Investigators
FDA investigators tied to this site in the record.
Charles B Steinmiller2 insp.
Samantha E Rafferty2 insp.
Meaghan M Rabideau1 insp.
Lavender M Huskey1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.103 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 111.70(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.105(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.113(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.16 | 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 111.25(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(l)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.30(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.453 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.503 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.553 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.560(a) | 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(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(c)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.75(a)(2)(ii)(A) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.83(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Osmosis, LLC's 3 Form 483s
Source PDFs 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