FDA 483 - The Wellness Center Pharmacy, Inc., dba Designer Drugs - December 12, 2017

An FDA inspection conducted between December 12 and December 22, 2017, at The Wellness Center Pharmacy, Inc., operating as Designer Drugs, a producer of sterile and non-sterile drugs, identified several critical deficiencies. The Form FDA 483 report documented issues primarily related to facility cleanliness and aseptic processing controls. Inspectors observed non-microbial contamination, specifically rust-like stains, on the clean room (ISO 7) floor and on a metal stool used during aseptic processing. Furthermore, the firm's media fill simulations were deemed inadequate because they did not accurately represent large-scale production, such as a 10-liter ophthalmic product batch packaged into 2,000 units, while media fills only tested 25 vials. The inspection also noted that ISO 5 aseptic processing areas contained dust-collecting overhangs that were not subject to adequate or frequent cleaning. A specific instance involved a dislodged plastic cover exposing an internal canopy/light fixture housing that lacked a proper cleaning procedure. These observations indicate potential deviations from current Good Manufacturing Practices (cGMP). The company is required to address these findings and propose corrective actions to the FDA to ensure compliance and product quality.