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# CGMP Violations at Newton Laboratories
- URL: https://www.fdaweb.com/cgmp-violations-at-newton-laboratories/
- Published: 2019-04-30T12:00:00.000Z
- Updated: 2026-09-15T01:23:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143986

A 3/26-3/30/18 FDA inspection at Newton Laboratories, Conyers, GA, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. A 4/23 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/newton-laboratories-inc-dba-newton-homeopathics-559612-04232019?ref=fdaweb.com) says the violations also included misbranded new drugs and unapproved new animal drugs. Specific violations identified in the letter were: 

- failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
- failing to establish written procedures for production and process controls designed to assure that the drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess;
- failing to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements;
- failing to maintain written records so that the quality standards of each drug product can be evaluated at least annually to determine the need for changes to drug product specifications or manufacturing control procedures.

Based on the nature of the violations and the fact that Newton did not correct repeat deficiencies, FDA recommends the company retain a qualified consultant to assist it in meeting CGMP requirements. The letter also details issues with misbranded human drugs, including some products represented as being homeopathic drugs, and unapproved animal drugs.

Newton was told to promptly correct the violations and to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.