FDA Inspection 612055 — Romark Laboratories, L.C.
The FDA completed an inspection of Romark Laboratories, L.C. on September 21, 2009 in Tampa, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 21, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Tampa, FL (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6829 | 21 CFR 314.80(c)(2) | Failure to report non-alert ADEs |
| 6830 | 21 CFR 314.80(c)(2) | Interval |