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FDA Inspection
•Newton Implant Systems, Inc.•August 18, 2025

Newton Implant Systems, Inc. – FDA Inspection, Aug 18, 2025

Record Details

This FDA Inspection record concerns Newton Implant Systems, Inc., with an inspection on August 18, 2025, issued by the Los Angeles District Office, covering biologics.

Company
Newton Implant Systems, Inc.
Inspection Date
August 18, 2025
Product Type
Biologics
Office
Los Angeles District Office
Person
  • Eric Zhu
View Company Profile

ID · fd95b7d3-dcf8-45ab-9f4e-14276b9c021b

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1278912
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies
Outcome
Form 483 issued, view the record

FDA Citations

1
  1. 21 CFR 1271.180(a)Procedures to meet core CTGP

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Newton Implant Systems, Inc.

1
DateClassificationOfficeProject area
July 19, 2022NAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
Other documents for Newton Implant Systems, Inc.
  • FDA Inspection 1174940 - 2022-07-19

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