1251408
Winder Laboratories, LLC — FEI 3008694072
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 5, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Winder, GA (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2011 | 21 CFR 211.188(a) | Accurate reproduction |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4355 | 21 CFR 211.165(c) | Sampling and testing plans not followed |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |
| 4368 | 21 CFR 211.188(b)(12) | Investigations made into any unexplained discrepancy |