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# CGMP Violations at Raritan Pharmaceuticals
- URL: https://www.fdaweb.com/cgmp-violations-at-raritan-pharmaceuticals/
- Published: 2017-06-27T12:00:00.000Z
- Updated: 2026-09-14T22:31:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139029

A 9/29-10/20/16 FDA inspection at Raritan Pharmaceuticals, East Brunswick, NJ, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to a 6/20 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm564194.htm?ref=fdaweb.com) from the agency’s New Jersey District Office. Specific violations cited in the letter are: 

- failing to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality;
- failing to have adequate written procedures for production and process controls designed to assure that the drug products the firm manufactures have the identity, strength, and/or purity they purport or are represented to possess; and
- failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet its specifications, whether or not the batch has already been distributed.

The letter also says the firm’s Homeopathic Infant’s Teething Tablets is considered a drug under the Federal Food, Drug, and Cosmetic Act, and is misbranded because FDA testing of samples found belladonna alkaloid content that varied widely from the content stated on the label, including some that far exceeded the labeled claim of alkaloids for the tablets.

The letter acknowledges that the firm initiated a recall after receiving notice of the laboratory findings indicating belladonna levels greatly exceeding the label claim. It also acknowledges the company’s statement that it no longer manufactures Homeopathic Infants’ Teething Tablets, Kid’s Ear Relief Liquid, and Diarrhea Relief tablets. It asks Raritan to confirm that it has permanently ceased production of those drugs or to indicate if it is considering resuming production at some time in the future.

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