FDA Inspection 728520 — ESB Enterprises L.L.C.
The FDA completed an inspection of ESB Enterprises L.L.C. on Jun 6, 2011 in Saint Charles, IL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 6, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Saint Charles, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 5043 | 21 CFR 1010.3(a)(1) | ID label lacks name and address |
| 5046 | 21 CFR 1010.3(a)(2)(ii) | Manufacture date abbreviated or unapproved date coding |
| 5234 | 21 CFR 1040.20(d)(3)(v) | False and misleading/prohibited statements |
| 5240 | 21 CFR 1040.20(e)(1)(v) | Repair/compatible replacement instructions |
| 5802 | 21 CFR 1002.13 | Lack of required elements |