FDA Inspection 579746 — Molded Products Inc
The FDA completed an inspection of Molded Products Inc on Mar 26, 2009 in Harlan, IA. 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). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 26, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Harlan, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |
| 3288 | 21 CFR 820.90(b)(1) | Documentation of disposition, justification, signature |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 538 | 21 CFR 820.70(a) | Process control procedures |