FDA Inspection 570891 — Hu-Friedy Mfg Co, Inc.
The FDA completed an inspection of Hu-Friedy Mfg Co, Inc. on March 3, 2009 in Chicago, IL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 3, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 3681 | 21 CFR 820.70(b) | Verification or validation of changes |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |
| 649 | 21 CFR 803.18(e) | Info not obtained or submitted |
| 733 | 21 CFR 803.50(b)(1) | Reporting Information Reasonably Known |
| 735 | 21 CFR 803.50(b)(3) | Conducting an Investigation |