FDA Inspection
Mountain Spirit LLC dba Mountain Spirit Herbal CompanyMountain Spirit LLC dba Mountain Spirit Herbal Company – FDA Inspection, Sep 30, 2015
Record Details
This FDA Inspection record concerns Mountain Spirit LLC dba Mountain Spirit Herbal Company, with an inspection on September 30, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 30, 2015
- Product Type
- Drugs
View Company Profile
ID · ed03a6a3-cf35-4c72-a322-4d33ec9a082e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 944991
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
10- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.122(a)Written procedures describing in detail
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.150Written distribution procedure
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.67(b)Written procedures fail to include
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Mountain Spirit LLC dba Mountain Spirit Herbal Company
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 29, 2022 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 14, 2018 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Mountain Spirit LLC dba Mountain Spirit Herbal Company
- FDA Inspection 1181908 - 2022-09-29
- FDA Inspection 1065534 - 2018-09-14
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.