# FDA 483 - Newton Laboratories, Inc. - September 17, 2021

Source: https://www.keypedia.com/records/483/newton-laboratories-inc/d1a4aea2-af5d-40ea-88f9-3e3ab729ca09

> FDA 483 for Newton Laboratories, Inc. on September 17, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Newton Laboratories, Inc.
- Inspection Date: 2021-09-17
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Newton Laboratories, Inc. in Conyers, GA, a homeopathic drug establishment, revealed a significant quality system deficiency. The firm's quality control unit failed to fully follow its change control procedures, implementing several changes without proper documentation, evaluation, or approval. This issue is a repeat observation from a previous FDA 483.

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Company: https://www.keypedia.com/companies/newton-laboratories-inc/61762181-8a34-4b74-8023-1be775d74406

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7