FDA 483 - Trone Health Services, Inc. - July 15, 2016

The FDA Form 483 details significant deficiencies in the facility's aseptic processing and quality control for drug products. Sterile drugs, including Acetylcysteine Ophthalmic 10% Solution and Gentamicin Irrigation Solution 80 MG/60 ML Solution, were produced in an unclassified AirClean Systems PowderSafe™ 700 series Ductless Balance Enclosure within an ISO 8 laboratory, not under the required ISO 5 conditions. The enclosure itself showed residue and stains, lacking controls for microbial, endotoxin, and chemical/physical contamination.

The facility lacks a written stability testing program. Expired Active Pharmaceutical Ingredients (APIs) and components were used in drug products, and their Beyond Use Dates (BUDs) or Discard After dates exceeded the API/component expiration. Examples include DHEA E4M 6MG, Acetylcysteine Ophthalmic 10% Solution, Testosterone Cypionate Sesame 200 MG/GM Injectable, Baclofen 20 MG/ML Oral Suspension, and Dream Cream (A/L-A/S/T) Cream. Inconsistencies between BUDs and "Discard After" dates for products like Acetylcysteine Ophthalmic 10% Solution and Baclofen 20 MG/ML Oral Suspension also lacked stability data.

Control procedures for mixing uniformity are inadequate; for DHEA CR 6 MG Capsule, manual mixing in a mortar and pestle