FDA 483 - JD & SN Inc. - July 12, 2017

This FDA Form 483 was issued to Shawn W. Needham, Pharmacist/Owner of JD & SN Inc., a producer of non-sterile drug products located in Moses Lake, WA. The inspection occurred from June 28, 2017, to July 12, 2017.

Two observations were noted. Observation 1 details inadequate cleaning of production and processing areas, equipment, and utensils, specifically concerning highly potent and hazardous drugs. Residual drug product, including (b)(4) and (b)(4), was found on surfaces, walls, ceilings, and equipment (e.g., balance touch screen, encapsulation machine) in (b)(4) hoods after end-of-production cleaning on June 29, 2017. The firm's practice does not require cleaning work surfaces prior to the start of production the following morning. Additionally, the effectiveness of household cleaning detergent for removing drug residuals from shared equipment and utensils used for hazardous and potent drugs (estradiol, progesterone, methimazole, fluconazole, methyltestosterone, testosterone, and tretinoin) is not assured. The current cleaning involves soaking and hand washing with commercial household dish detergent, followed by dishwasher cleaning or hand washing for non-dishwasher safe items, with no sanitizing agent used.

Observation 2 states that the walls and ceiling of the (b)(4) hoods are not cleaned between drug productions to remove drug residuals;