FDA Inspection 651544 — Hearthside Food Solutions, LLC
The FDA completed an inspection of Hearthside Food Solutions, LLC on Mar 15, 2010 in Lakeville, MN. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 15, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Lakeville, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1849 | 21 CFR 211.84(d)(6) | Objectionable microbiological contamination |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |