FDA Inspection
Green Hills Health and Wellness Pharmacy IncGreen Hills Health and Wellness Pharmacy Inc – FDA Inspection, Oct 22, 2014
Record Details
This FDA Inspection record concerns Green Hills Health and Wellness Pharmacy Inc, with an inspection on October 22, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 22, 2014
- Product Type
- Drugs
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ID · 5c17bf90-c27a-49d4-922f-c701397d6c3e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 901765
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- 483 Response
FDA Citations
7- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
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Other FDA inspections of Green Hills Health and Wellness Pharmacy Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 5, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 28, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Green Hills Health and Wellness Pharmacy Inc
- FDA Inspection 675120 - 2010-08-05
- FDA Inspection 660199 - 2010-04-28
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