Raritan Pharmaceuticals, Inc. FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

product of acceptable quality with consistent attributes. Process validation studies lacked data to demonstrate that the process is capable of reproducibly yielding finished drugs that consistently meet label claims. Our investigators collected samples in which FDA detected atropine and scopolamine in belladonna teething tablets at concentrations that demonstrated highly variable levels of active ingredient in finished units. These tablets also contained belladonna content that was much higher than both finished product label claims and the purported content of the(b)(4)component.

In response to this letter, provide your scientific approach for characterizing and qualifying analytical standards used in process validation activities. Regarding your process validation program, include a data-driven and scientifically sound program that appropriately identifies and controls sources of variability, such that the finished product will consistently meet its quality attributes and label claims.

Your firm’s product, “Homeopathic Infant’s Teething Tablets” is a drug under section 201(g)(1) of the FD&C Act [21 U.S.C. 321(g)(1)], because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or because it is intended to affect the structure or any function of the body. Examples of claims that establish the intended uses for “Homeopathic Infant’s Teething Tablets” include, but may not be limited to, the following:

Potential Health Risks

Dr. Vin K. NayakPresidentRaritan Pharmaceuticals, Inc.8 Joanna CourtEast Brunswick, NJ 08816

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Raritan Pharmaceuticals, Inc. at 8 Joanna Court, East Brunswick, New Jersey, from September 29 to October 20, 2016.

This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.

Regulatory Context

Because your methods, facilities or controls for, manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

In addition, based on our review of the labeling, “Homeopathic Infant’s Teething Tablets” is a misbranded drug in violation of sections 502 and 301(a) of the FD&C Act, 21 U.S.C. 352 and 331(a).

During our inspection, our investigators observed specific violations including, but not limited to, the following: