FDA Inspection 538700 — Hammill Manufacturing Company
The FDA completed an inspection of Hammill Manufacturing Company on November 10, 2008 in Maumee, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 14 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 10, 2008
- 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 |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3284 | 21 CFR 820.90(a) | Nonconforming product evaluation/investigation |
| 3299 | 21 CFR 820.100(a)(1) | Procedure for analysis of data sources |
| 3670 | 21 CFR 820.20(c) | Management review participants |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |
| 538 | 21 CFR 820.70(a) | Process control procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |