An FDA Warning Letter was issued to a sprouting operation after inspection observations found a number of serious violations that remained uncorrected. Of high concern was grey sludge material falling into and accumulating in growing sprouts which could not be confirmed as a food-grade material. Although the company stated in the inspection closeout meeting that it would discard the potentially contaminated sprouts, the sprouts were introduced into commerce the following month.
Other insanitary condition violations included chipped and peeling paint on ceilings, pitted and cracked floors, and a hose used for rinsing food contact surfaces lying on the floor and not cleaned and sanitized before use. And inspectors noted pest concerns of rodent excreta pellets observed in the packaging room where RTE sprouts were stored and harborage conditions (e.g., vegetation) observed around the facility that could potentially attract pests. Although the company’s third-party pest control company recommended actions to prevent recurrence, the facility had not implemented any of these recommended actions.
Not only did FDA not receive any documentation that corrective action was taken on any of the concerns, pest control, building maintenance, and employee handling practices were repeat observations from a previous inspection. Thus, the facility was issued a warning letter and given 15 days to notify FDA in writing of the specific steps taken to address the violations.
While regulatory violations on a 483 are an issue, they also are an opportunity to make corrections. And the lack of doing so not only puts the facility at risk of legal action by FDA but also puts the company’s consumers at risk of contaminated product.
