FDA Inspection
Ridge Properties, LLCRidge Properties, LLC – FDA Inspection, Mar 16, 2017
Record Details
This FDA Inspection record concerns Ridge Properties, LLC, with an inspection on March 16, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 95f0f7ae-84b8-4d97-abe8-616ee53e6b8e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1009107
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
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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 30, 2018 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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