FDA 483 - Pharm D Solutions, LLC - August 28, 2018

The FDA Form 483 details numerous deficiencies at a drug compounding facility. Key issues include inadequate procedures to prevent microbiological contamination of sterile drug products, specifically media fills not simulating worst-case conditions and observed aseptic practice deficiencies during compounding of Trimix Lyophilized Powder. The firm failed to reject batches of sterile drug product that did not meet potency or sterility specifications and did not perform 100% visual inspection of all sterile drug products.

Environmental monitoring was deficient, lacking alert/action level limits and showing dried-up EM plates. Laboratory testing was insufficient, with no testing for endotoxin and potency on high-risk compounded batches, and no testing for preservative content or dissolution for Testosterone pellets. Production and process controls lacked written procedures to assure drug product identity, strength, quality, and purity. The lyophilization process was deficient, lacking validation, 100% visual inspection of lyophilized products, and adequate recording devices.

Cleaning and disinfection procedures for aseptic processing areas were inadequate, as was equipment maintenance. Investigations into unexplained discrepancies, environmental monitoring excursions, and yeast/mold recovery were lacking. Personnel clothing was inappropriate. The stability testing program was deficient, with BUDs not determined by stability-indicating assays and exceeding raw material expiry. Labeling controls were poor, with inaccurate labeling, reconditioning performed without pharmacist notification, and incomplete batch records lacking label specimens. Finally, the outsourcing facility failed to submit required six-month drug compounding reports to the FDA.