FDA Inspection
Ashland Specialty Ingredients, G.P.Ashland Specialty Ingredients, G.P. – FDA Inspection, Aug 7, 2025
Record Details
This FDA Inspection record concerns Ashland Specialty Ingredients, G.P., with an inspection on August 7, 2025, issued by the New Jersey District Office, covering medical devices & rad health.
- Inspection Date
- August 7, 2025
- Product Type
- Medical Devices & Rad Health
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ID · 9e92c00d-89ac-4db5-a244-257b7414dc2f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1277706
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Ashland Specialty Ingredients, G.P.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 10, 2025 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| February 17, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 21, 2017 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Ashland Specialty Ingredients, G.P.
- FDA Inspection 1282952 - 2025-09-10
- FDA Inspection 1197717 - 2023-02-17
- FDA Inspection 1031818 - 2017-11-21
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