FDA Inspection 683308 — Green Pharmaceuticals, Inc.
The FDA completed an inspection of Green Pharmaceuticals, Inc. on September 15, 2010 in Camarillo, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 15, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Camarillo, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1725 | 21 CFR 211.134(c) | Examinations documented |
| 1774 | 21 CFR 211.142(a) | Quarantine - actual practice |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2004 | 21 CFR 211.184(d) | Labeling: documentation of exam and review |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 4359 | 21 CFR 211.170(b)(1) | Retention time of reserve samples, in general |