11 November 2024
Initial batches will be manufactured concurrently with ongoing quality activities and will only be released in accordance with applicable regulatory requirements to ensure the quality and safety of the products, whilst the company reports that the earliest that new North Cove product could start to ship is late November. Assessment and repair of equipment with phased testing continues to progress across all other production lines, which will, in coordination with FDA, support resumption of operations in phases. The company does not yet have a timeline for when it expects North Cove production to be fully restored to pre-hurricane levels.