FDA Inspection 582130 — Yates Motloid Co
The FDA completed an inspection of Yates Motloid Co on May 13, 2009 in Elmhurst, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 13, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Elmhurst, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3167 | 21 CFR 820.198(a) | Complete files maintained |
| 3299 | 21 CFR 820.100(a)(1) | Procedure for analysis of data sources |
| 3371 | 21 CFR 820.198(a)(3) | Processing MDRs {see also 803, 804} |
| 3417 | 21 CFR 820.70(a)(2) | Production monitoring and control |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4060 | 21 CFR 820.20(b)(3)(i) | Management representative implementing the quality system |
| 4168 | 21 CFR 820.100(a)(7) | Management review of CAPA |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |