unapproved

He said his wife was “killed in the prime of her life in her own home after being unlawfully injected with unsafe and unapproved substances by Libby Adame, an unlicensed individual falsely holding herself out as qualified to perform cosmetic procedures,” according to the civil complaint.

They also fear the state is on shaky legal ground with federal regulators who have, in recent years, cracked down on businesses offering certain unapproved therapies.

Company executives said they are clear-eyed about the potential harms with unapproved therapies.

Each time regulators promise reform, contaminated syrups reappear - reflecting a fragmented drug market and, critics allege, a weak regulatory system struggling to oversee hundreds of low-cost, often unapproved syrups produced by smaller manufacturers and sold over the counter.

The EY records said Tetra Tech filed time sheets for unapproved costs, without sufficient supporting information, with questionable or excessive hours, with digital alterations that increased hourly rates, and without proper supervisor approvals.