FDA Inspection 1031818 — Ashland Specialty Ingredients, G.P.
The FDA completed an inspection of Ashland Specialty Ingredients, G.P. on Nov 21, 2017 in Bridgewater, NJ. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Nov 21, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Bridgewater, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 3683 | 21 CFR 820.70(g) | Equipment Installation, Placement, Specified Requirements |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |