FDA 483 - New England Life Care, Inc. dba Advanced Compounding Solutions - August 22, 2017

The FDA Form 483 inspection revealed multiple deficiencies at the facility. From June 22 to July 24, 2017, the firm failed to conduct potency testing for Phenylephrine drug products (40mcg/mL, 80mcg/mL, and 100mcg/mL) prefilled syringes. Sixteen batches were released without potency testing, and four batches (approximately 1,100 prefilled syringes) were distributed to client hospitals.

Aseptic processing areas were deficient in environmental monitoring. Active air sampling for viable and non-viable particulates was not performed within the ISO 5 Laminar Flow Hood during aseptic operations, only post-operations. Settle plates were improperly placed. Differential pressure of ISO 5 Laminar Flow Hoods was only monitored at the beginning of operations. Since June 22, 2017, 87 lots of sterile products were produced, with two (Phenylephrine 40mcg/mL and 100mcg/mL) commercially distributed to Massachusetts hospitals/medical centers.

Equipment requalifications for the four Baker ISO 5 Laminar Flow Hoods were inadequate, as static and dynamic smoke studies did not demonstrate unidirectional airflow or capture routine setup conditions. Aseptic process simulations (media fills) were insufficient, not representing all critical procedures or appropriate scale for commercial operations (e.g., 2% of routine fill size