FDA Cites New Jersey Manufacturer for GMP Violations

FDA sent a warning letter, dated June 20, 2017, to Raritan Pharmaceuticals, Inc. in response to violations found during an inspection of the company’s East Brunswick, NJ facility from Sept. 29–Oct. 20, 2016. The violations ranged from misbranding to inadequate quality testing and procedures.

According to the warning letter, the company failed to test samples of components for identity and conformity with quality specifications. After sampling product lots, FDA inspectors found “that the material was not homogenous in composition and exhibited high variability, which render it of unacceptable quality. Because the component was not of uniform character and quality, it should not have been released for use in the manufacture of drug products. This variability exposes infants and children who are given your drugs to potentially significant safety hazards from belladonna levels far beyond the labeled content.”

Appropriate written process control procedures were also lacking. Inspectors found that the company’s manufacturing procedures were not supported by adequate process validation. “Process validation studies lacked data to demonstrate that the process is capable of reproducibly yielding finished drugs that consistently meet label claims,” FDA stated in the letter.

Batch failure investigation was also not properly performed. Complete analysis of customer complaints was not documented and specific investigations were not conducted.

The agency also cited the company for misbranding of drug products. The letter stated that while the company labels its products as homeopathic, they are still subject to the same regulations as other drugs. “Under section 502(a) of the FD&C Act [21 U.S.C. 352(a)], a drug is misbranded if its labeling is false or misleading in any particular. FDA’s test results on samples of ‘Homeopathic Infant’s Teething Tablets’ indicate alkaloid content that widely varies from the content stated on the product labeling, including alkaloid content that far exceeded the labeled claim of alkaloids for ‘Homeopathic Infant’s Teething Tablets,’” the agency stated in the letter.

Raritan Pharmaceuticals recalled product after FDA laboratory findings found the increased belladonna levels and has stated it no longer manufactures Homeopathic Infants’ Teething Tablets, Kid’s Ear Relief Liquid, and Diarrhea Relief tablets. FDA requested in the warning letter that the company confirm for the agency that it has permanently ceased production of these drugs and that the company must notify the agency if it resumes production in the future.

Source: FDA