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FDA Inspection
•Ashland Specialty Ingredients, G.P.•November 21, 2017

Ashland Specialty Ingredients, G.P. – FDA Inspection, Nov 21, 2017

Record Details

This FDA Inspection record concerns Ashland Specialty Ingredients, G.P., with an inspection on November 21, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company
Ashland Specialty Ingredients, G.P.
Inspection Date
November 21, 2017
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Esteban Beltran (Issuing Officer)
View Company Profile

ID · 5717ce59-4147-4bdb-b752-a09062d92089

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1031818
FDA center
Medical Devices & Rad Health
Project area
Radiation Control and Health Safety Act
Outcome
Form 483 issued

FDA Citations

6
  1. 21 CFR 820.100(b)Documentation
  2. 21 CFR 820.184DHR content
  3. 21 CFR 820.30(g)Design validation - software validation not performed
  4. 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
  5. 21 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements
  6. 21 CFR 820.75(a)Lack of or inadequate process validation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Ashland Specialty Ingredients, G.P.

3
DateClassificationOfficeProject area
September 10, 2025NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
August 7, 2025VAINew Jersey District OfficeCompliance: Medical Devices
February 17, 2023NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
Other documents for Ashland Specialty Ingredients, G.P.
  • FDA Inspection 1282952 - 2025-09-10
  • FDA Inspection 1277706 - 2025-08-07
  • FDA Inspection 1197717 - 2023-02-17

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