FDA Inspection
Ridge Properties, LLCRidge Properties, LLC – FDA Inspection, Mar 30, 2018
Record Details
This FDA Inspection record concerns Ridge Properties, LLC, with an inspection on March 30, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 3a33da4c-c9e4-4c59-82df-204ed3962606
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1046210
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.101(d)Component release checked by 2nd person
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.134(c)Examinations documented
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.56(b)Written sanitation procedures not followed
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Other FDA inspections of Ridge Properties, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 8, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 16, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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