FDA Inspection 635745 — Harry J Bosworth Company
The FDA completed an inspection of Harry J Bosworth Company on Dec 14, 2009 in Skokie, 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 14, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Skokie, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 4060 | 21 CFR 820.20(b)(3)(i) | Management representative implementing the quality system |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |