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

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

Aseptic processing areas exhibited deficiencies 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 for passive sampling were improperly placed. Differential pressure of ISO 5 Laminar Flow Hoods was only monitored once at the beginning of sterile-to-sterile operations, not continuously. Since June 22, 2017, 87 lots of sterile products were produced, with two (Phenylephrine 40mcg/mL and 100mcg/mL) commercially distributed.

Equipment control over air pressure and microorganisms was inadequate. Requalifications of the four Baker ISO 5 Laminar Flow Hoods were insufficient, as static and dynamic smoke studies did not accurately represent actual setup and aseptic operations, failing to consistently demonstrate unidirectional airflow.

Procedures to prevent microbiological contamination were