The COVID-19 pandemic has put a damper on the FDA's on-site inspections in 2020, but that doesn't mean the agency isn't making the rounds and putting drugmakers on notice. A second U.S. company making prescription thyroid meds is on the receiving end of FDA's ire this year for potency concerns.
FDA investigators cited Phoenix-based RLC Labs for failing to adequately address a host of quality-control issues that led to the recall of 483 lots of two of the company's thyroid meds, according to a warning letter posted online Tuesday.
During an inspection between February and March, the FDA found that RLC employees failed to ensure its products met quality-control standards for potency and conformity, thanks to a dearth of written policies and the lack of an adequate quality-control unit.
Of 10 sampled lots of the company's WP Thyroid and Nature-Throid, the FDA found six samples with subpar potency, which can produce moderate to severe symptoms in patients with hypothyroidism, the agency said. Those issues led RLC to recall the 483 total lots of both drugs in September.
The FDA tied to those potency concerns to RLC's lack of written procedures to ensure the drug hit its marks, as well as potentially underpowered active pharmaceutical ingredients (API) imported from a third-party manufacturer.
The drugmaker also failed to adequately empower and train its quality-control team, the FDA found. In one glaring example of the unit's communication breakdown, RLC's quality team was apparently unaware of a list of "complaints" about the two drugs maintained in spreadsheets outside of its records. Those complaints included concerns about the drugs' potency, the FDA said, and were not investigated by the unit.
RLC responded that it would address the FDA's concerns, but the agency found those measures lacking, according to the letter.
RLC is the most recent drugmaker to take the FDA's lashing over underpowered thyroid meds after Georgia-based Acella Pharmaceuticals was cited for similar concerns last month.
The FDA knocked Acella after quality control issues with a contract manufacturer led the drugmaker to pull lots of its prescription NP Thyroid med off shelves back in May, according to a warning letter posted in September.
During an investigation between December and January, FDA investigators found Acella failed to use appropriate assays for the contract-manufactured API used in its drug, a combination of the ingredients levothyroxine and liothyronine.
While Acella eventually corrected those errors, a May follow-up FDA investigation at its CMO's facility found that 13 lots of NP Thyroid exceeded the specified strength. Acella agreed the same month to recall those lots and acknowledged two side-effects reports.