FDA 483 - W & C dba The Apothecary - July 30, 2018

On July 30, 2018, the FDA issued a Form 483 to W & C Apothecary dba The Apothecary, a producer of non-sterile drugs located in Sartell, MN, following an inspection conducted from July 23-30, 2018. The inspection identified one observation regarding inadequate cleaning procedures.

The firm was observed producing beta-lactam and highly potent drugs without providing adequate cleaning of work surfaces and utensils to prevent cross-contamination. Specifically, three batches of ceftazidime (03201710@12, 23201801@11, 15201805@20) were produced between October 2017 and May 2018 in (b)(4) hoods #1 and #2. These batches were made without adequate inactivation of the drug in the work area and on equipment. Batch records for two batches indicated the use of (b)(4) and (b)(4) for cleaning, while one indicated only (b)(4). The Pharmacist-In-Charge stated that only (b)(4) was used, and batch records indicating otherwise were inaccurate. The FDA noted that products made after these ceftazidime batches, such as duloxetine/oil suspension and progesterone capsules, were at risk of cephalosporin cross-contamination.

Additionally,