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FDA Inspection
•Scientific Molding Corporation Ltd.•February 8, 2019

Scientific Molding Corporation Ltd. – FDA Inspection, Feb 8, 2019

Record Details

This FDA Inspection record concerns Scientific Molding Corporation Ltd., with an inspection on February 8, 2019, issued by the San Francisco District Office, covering medical devices & rad health.

Company
Scientific Molding Corporation Ltd.
Inspection Date
February 8, 2019
Product Type
Medical Devices & Rad Health
Office
San Francisco District Office
Person
  • Quynh Strandberg (FDA Associated Person)
View Company Profile

ID · 9c3b393f-2146-4412-8e3e-a33816a3ad17

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1080458
FDA center
Medical Devices & Rad Health
Project area
Project Evaluation: Devices
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 820.100(a)Lack of or inadequate procedures
  2. 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 Scientific Molding Corporation Ltd.

1
DateClassificationOfficeProject area
August 20, 2026NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Scientific Molding Corporation Ltd.
  • FDA Inspection 1332068 - 2026-08-20

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