FDA Inspection
Ridgecrest Herbals, IncRidgecrest Herbals, Inc – FDA Inspection, Nov 17, 2016
Record Details
This FDA Inspection record concerns Ridgecrest Herbals, Inc, with an inspection on November 17, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b30b0fd3-4bdb-466e-a988-ac42d43d176c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 998553
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.140(b)(3)(iii)Records material review, disposition, follow-up; evaluation
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Other FDA inspections of Ridgecrest Herbals, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 17, 2018 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| December 4, 2012 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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