FDA Inspection
MSM Nutraceuticals, LLC dba MSM Health SolutionsMSM Nutraceuticals, LLC dba MSM Health Solutions – FDA Inspection, May 8, 2019
Record Details
This FDA Inspection record concerns MSM Nutraceuticals, LLC dba MSM Health Solutions, with an inspection on May 8, 2019, issued by the Denver District Office, covering human drugs.
- Inspection Date
- May 8, 2019
- Product Type
- Human Drugs
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ID · 8bfe655a-f16c-45e1-9427-103d8c13133b
Inspection Facts
- Inspection number
- 1089011
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.170(b)(1)Retention time of reserve samples, in general
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
Full citation text and observation details available on the Dashboard.
Other FDA inspections of MSM Nutraceuticals, LLC dba MSM Health Solutions
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 15, 2019 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| April 6, 2017 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for MSM Nutraceuticals, LLC dba MSM Health Solutions
- FDA Inspection 1077340 - 2019-01-15
- FDA Inspection 1009076 - 2017-04-06
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