Overview
- 17 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.
17 Oct 2023
21 CFR 111.210(a)
Master manufacturing record - dietary ingredients
Cited by Martin R Vowell, Brittany A Mckenzie
17 Oct 2023
21 CFR 111.210(g)
Packaging description, representative label
Cited by Martin R Vowell, Brittany A Mckenzie
17 Oct 2023
21 CFR 111.210(h)(1)
Instructions; specifications; quality
Cited by Martin R Vowell, Brittany A Mckenzie
17 Oct 2023
21 CFR 111.210(h)(3)
Master manufacturing record - specific actions; quality
Cited by Martin R Vowell, Brittany A Mckenzie
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 111.70(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 111.155(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.210(h)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(j)(2)(ii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(j)(2)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(j)(2)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.260(l)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 111.65 | 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)(C) | Cited across public-safe Form 483 observations | 1x |
Source document
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Form 483 source document
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Full 483 report
Get the verbatim text of all 17 observations
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- 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