Overview
- 16 public-safe observations are available for this inspection.
- 16 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
18 Feb 2026
21 CFR 111.105(a)
Quality control - processes, specifications, written procedures
Cited by Courtney E Hillier, Hassan M Fakhreddine
18 Feb 2026
21 CFR 111.160(c)(3)
Packaging - quality control; approve, release
Cited by Courtney E Hillier, Hassan M Fakhreddine
18 Feb 2026
21 CFR 111.165(c)(2)
Product received - quality control; documentation; specs
Cited by Courtney E Hillier, Hassan M Fakhreddine
18 Feb 2026
21 CFR 111.205(a)
Master manufacturing record - prepared
Cited by Courtney E Hillier, Hassan M Fakhreddine
18 Feb 2026
21 CFR 111.255(b)
Batch record - complete
Cited by Courtney E Hillier, Hassan M Fakhreddine
Inspected site
SESpartan Enterprises Inc. dba Watershed Wellness CenterLansing, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.105(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.160(c)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.165(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.205(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.255(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.27(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.415(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.453 | 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(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.70(g) | 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) | 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(h) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 16 observations
The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere