FDA Inspection 610841 — Hammill Manufacturing Company
The FDA completed an inspection of Hammill Manufacturing Company on September 2, 2009 in Maumee, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 2, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Maumee, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3155 | 21 CFR 820.181(a) | DMR device specifications |
| 3156 | 21 CFR 820.181(b) | DMR production process specifications |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3283 | 21 CFR 820.90(a) | Specific non-conforming product procedures |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |