FDA Inspection 614153 — Johnson Creek Enterprises, LLC
The FDA completed an inspection of Johnson Creek Enterprises, LLC on September 25, 2009 in Hartland, WI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 25, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hartland, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1632 | 21 CFR 211.130(c) | Lot or control number assigned |
| 1725 | 21 CFR 211.134(c) | Examinations documented |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |