FDA Inspection 680212 — Lymol Medical Corporation
The FDA completed an inspection of Lymol Medical Corporation on September 14, 2010 in Woburn, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 14, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Woburn, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |