FDA INVESTIGATORS CONFIRM CONTAMINATION IN 50 OF 50 VIALS TESTED
COMMENT
The FDA issued its initial Form FDA 483 regarding the New England Compounding Center located in Framingham, MA. The eight page, five item 483 describes the initial findings of their audit. The Company now has 15 business days to submit its response to the FDA. Of particular note is that section of Observation 2 (see below) that “the firm provided no documentation or evidence to support that the steam autoclave cycle used to sterile suspensions formulated using non-sterile API and raw material is effective.”
OBSERVATIONS
As noted within Observation 1, “the FDA analysis of FDA Sample #693965, consisting of methylprednisolone acetate (preservative free) 80 mg/ml, 1 mL filled vials from Lot#08102012@51 collected from the firm, confirmed the presence of viable microbial growth in 50/50 vials tested. One vial examined microscopically showed fungal morphological features.”
Observation 2. Although the formula worksheets state the raw materials are sterile, the Pharmacy Director stated that the firm uses non sterile active pharmaceutical ingredient (APIs)a and raw materials, with the exception of sterile water for injection, to formulate injectable suspensions including but not limited to preservative free methylprednisolone acetate and triamcinolone. During the inspection, we observed that the labeling for the methylprednisolone acetate API and additional raw materials did not indicate that they were sterile. Samples were collected for analysis of the non-sterile API and 3 additional raw materials used in the formulation of methylprednisolone acetate. The firm provided no documentation or evidence to support that the steam autoclave cycle used to sterile suspensions formulated using non-sterile API and raw material is effective.
Please visit the balance of the Observations at:
