FDA Inspection 1023315 — Exact-Rx Inc
The FDA completed an inspection of Exact-Rx Inc on August 29, 2017 in Melville, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 29, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Melville, NY (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 10022 | 21 CFR 310.305(a) | Failure to develop written procedures |
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |