FDA Sues California Manufacturer of Dietary Supplements for Repeated cGMP Violations

WASHINGTON—A California-based contract manufacturer of dietary supplements that was accused of repeated violations of current Good Manufacturing Practices (cGMPs) has entered a consent decree with the federal government.

Scilabs Nutraceuticals, Inc. and its CEO, Paul Edalat cannot operate until establishing that the facility is in full compliance with cGMPs and has met a number of other conditions under the consent decree.

Scilabs is a manufacturer of dietary supplements that are distributed under the brand name All Pro Science, according to a complaint filed against the company in federal court by the U.S. Justice Department on behalf of FDA. The products include Complete Immune+ capsules and flavored powders called Complete, Recovery and Precharge, the complaint stated.

Under a consent decree signed on Nov. 12 by U.S. District Judge Josephine Staton, Scilabs also must recall and destroy products that were held, made and distributed between Aug. 1, 2012 and the date the decree was entered.

FDA has inspected Scilabs’ facility in Irvine, California for three straight years, and the most recent inspection was conducted in January and February of 2004.

The four-day inspection established that the company is manufacturing adulterated supplements because the products fail to comply with FDA’s cGMPs, according to the U.S. Department of Justice, which filed the lawsuit on Nov. 4 in the U.S. District Court for the Central District of California (8-14-CV-1759).

Stephen Cook, a Brown Rudnick LLP lawyer representing Scilabs, said the company received notification a few months ago that FDA intended to file a complaint.

Rather than litigate the case, “we felt the resources were better spent entering into an agreement to work cooperatively with them to satisfy their concerns and enhance the standards that were in place at the facility," said Cook, a former federal prosecutor, in a phone interview.

In the 16-page consent decree, Scilabs neither admitted nor denied the allegations in the government's complaint, and the company disclaimed any liability.  

The government's complaint cited seven distinct violations, including failure to verify the identity of every component that is a dietary ingredient before using the component through a test or examination. Additional alleged infractions included failure to establish product specifications for identify, purity, strength and composition of finished dietary supplement batches; and failure to establish and follow written procedures for the responsibilities of the quality control operations.

A number of the infractions were the same ones FDA observed during a previous inspection in the fall of 2013, according to the government. FDA also noted cGMP deficiencies during a 2012 inspection of Scilabs’ facility.

The case is emblematic of FDA’s tendency to officially warn a company in a letter that forthcoming enforcement action—such as a lawsuit—is a possibility if they fail to come into compliance with the Federal Food, Drug, and Cosmetic Act.

Daniel Fabricant, executive director and CEO of the Natural Products Association (NPA), said FDA doesn’t have to send a warning letter before filing a lawsuit. Fabricant, the former top supplement official at FDA, said the agency is more likely to move in court without first issuing a warning letter if there is a public health threat or a firm is grossly negligent in its obligations to comply with cGMPs. Government lawyers did not cite any illnesses associated with Scilabs’ products.

“FDA strengthens its injunction actions by demonstrating in the complaint that FDA made and has documented a conscious effort to get the objectionable products or practices corrected without court involvement. For example, the defendants were notified of the violations (by letter, FDA 483, meeting, telephone call) and, despite having an opportunity to correct the violations, failed to do so," the agency states in a regulatory procedures manual concerning injunctions. "Prior notice is not a legal requirement, but can demonstrate a defendant’s resistance to compliance and enhance the agency’s request for court intervention.”

In the case against Scilabs, the company received prior notice. On Jan. 25, 2013, FDA issued a warning letter to Edalat, detailing cGMP violations that were observed during the July/August 2012 inspection. The FDA and Justice Department contend the defendants’ subsequent promises to correct the deficiencies were empty ones, as illustrated by FDA’s findings in the latest inspection.

Under the consent decree, Scilabs must retain an expert who will submit a report to FDA that the company is in compliance with cGMPs, including a number of regulations that the company allegedly failed to comply with.

Even after FDA authorizes the company to resume operations, Scilabs must retain an auditor to inspect its facilities at least once every six months for five years and then at least once a year.

Scilabs' products are distributed in several states through All Pro Science, Inc., including in Oregon, Arizona, Utah, Oklahoma and Illinois, according to the complaint.

All Pro Science (APS) "is in the process of transitioning its contract manufacturing requirements to another qualified lab, while Scilabs conducts the review required by its agreement with the FDA," said Farah Barghi, chief operating officer of the company, in an email.

"APS is not affiliated with Scilabs Nutraceuticals, Inc. beyond contract manufacturing," Barghi added.