FDA Inspection 759069 — Lymol Medical Corporation
The FDA completed an inspection of Lymol Medical Corporation on Dec 15, 2011 in Woburn, MA. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 15, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Postmarket Surv. and Epidemiology
- Location
- Woburn, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6832 | 21 CFR 314.80(c)(2) | Late submission of annual safety reports |