Phase 4 Pharmaceutical LLC FDA Warning (2018)

Detailed Analysis

False Claims and Regulatory Violations

2. Your firm failed to establish and follow written procedures designed to assure that correct labels, labeling, and packaging materials are used for the products, including procedures to prevent mix-ups and crosscontamination by physical or spatial separation from operations on other drug products (21 CFR 211.130(a))

Your firm lacks controls and/or records necessary to prevent product mix-ups during repackaging and labeling operations. Your firm receives bulk deliveries of different kinds of transdermal patches from a contract manufacturer, and you then repackage your drug products into zippered plastic bags along with the product labels. These different drug products are similar in appearance and have no identifying labels on them, which may result in product and labeling mix-ups at your firm.

Violations cited in this letter are not intended as an all-inclusive list. You are responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations.

Potential Health Risks

Stephen M. Lapidus, OwnerPhase 4 Pharmaceutical, LLC21055 N.E. 37th Ave., Suite 2202Aventura, Florida 33014

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Phase 4 Pharmaceutical, LLC (FEI: 3008862488) at 21055 N.E. 37th Ave., Suite 2202, Aventura, Florida 33014, from April 26 to May 2, 2017.

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).

During our inspection, our investigator observed specific violations including, but not limited to, the following.

1. Your firm failed to establish a quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).