Phase 4 Pharmaceutical Llc – FDA Warning Letter, May 2, 2017

The FDA inspected Phase 4 Pharmaceutical, LLC from April 26 to May 2, 2017, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated. The firm repackages OTC transdermal patches.

Key violations include: 1. **Lack of Quality Control Unit:** The firm failed to establish a quality control unit with authority to approve/reject materials and products, and lacked written procedures for repackaging and QC responsibilities. Their response referenced inapplicable food regulations and an intention to switch to "homeopathic topical applications," which the FDA clarified are still considered drugs and must meet CGMP. 2. **Inadequate Labeling and Packaging Controls:** The firm lacked procedures to prevent mix-ups and cross-contamination during repackaging and labeling. Different drug products, similar in appearance and lacking identifying labels, were repackaged into zippered plastic bags with labels, increasing mix-up risk. 3. **Insufficient Distribution System for Recalls:** The firm lacked procedures for drug distribution and did not document lot numbers, preventing traceability for recalls. 4. **Unsupported Expiration Dates:** Repackaged OTC skin patches lacked expiration dates, and the firm had no stability data to support the zippered plastic bags as an appropriate container-closure system.

Additionally, FDA testing of products (Power Patch, Female Libido Formula Patch, DHEA Skin Patch for Men, Skin Patch for Women) found multiple samples to be subpotent with no