FDA 483 - SKNV - September 17, 2018

The FDA Form 483 inspection revealed multiple deficiencies in the firm's manufacturing and quality control processes for non-sterile drug products.

A key observation was the use of non-pharmaceutical grade components, specifically (b)(4) or (b)(4) Solution, in drug formulations without supporting documentation or microbial testing. The firm also failed to conduct release testing for potency on each batch of drug product, citing examples such as Fluocinolone Acetonide/Minoxidil/Tretinoin and Tacrolimus 0.1%.

In-process control procedures were found to be deficient, lacking examination of mixing adequacy and validation of formulary procedures to ensure homogeneity and blend uniformity. The firm also lacked a written testing program for assessing drug product stability, with no stability testing performed to determine shelf-life for products like Magnesium sulfate in 5% Dextrose and Hydroquinone 8%.

Furthermore, the firm failed to thoroughly review unexplained discrepancies and conduct root cause investigations for multiple patient complaints involving adverse events like redness, rash, hives, itching, or swelling from products such as Lidocaine/Tetracaine and Niacinamide/Tretinoin.

Finally, written procedures for cleaning and maintenance of equipment and utensils were not established. The firm produced hazardous drugs, hormones, and antibiotics in a non-sterile environment without adequate cleaning validation studies for work surfaces, utensils, and personnel, raising concerns about cross-contamination.