FDA Inspection 707152 — Golden State Medical Supply Inc.
The FDA completed an inspection of Golden State Medical Supply Inc. on February 2, 2011 in Camarillo, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 2, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Camarillo, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4355 | 21 CFR 211.165(c) | Sampling and testing plans not followed |