FDA Inspection
Green Pharmaceuticals, Inc.Green Pharmaceuticals, Inc. – FDA Inspection, Sep 15, 2010
Record Details
This FDA Inspection record concerns Green Pharmaceuticals, Inc., with an inspection on September 15, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Green Pharmaceuticals, Inc.
- Inspection Date
- September 15, 2010
- Product Type
- Drugs
View Company Profile
ID · 6bd92ed2-4584-478e-8ce3-3c22c4c94ee3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 683308
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.142(a)Quarantine - actual practice
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.170(b)(1)Retention time of reserve samples, in general
- 21 CFR 211.188(b)(8)Labeling Control Records and Label Copies
- 21 CFR 211.184(d)Labeling: documentation of exam and review
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.134(c)Examinations documented
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Other FDA inspections of Green Pharmaceuticals, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 9, 2024 | Not classified | Los Angeles District Office | |
| June 8, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 30, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Green Pharmaceuticals, Inc.
- FDA Inspection 1240188 - 2024-05-09
- FDA Inspection 1024144 - 2017-06-08
- FDA Inspection 732534 - 2011-06-30
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