A California-based food manufacturer, Oceanitan, Inc., has been issued a warning letter by the Food and Drug Administration (FDA) for significant violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation. The FDA’s action comes in response to a consumer complaint related to a case of infant botulism, prompting an inspection of Oceanitan, Inc.’s food manufacturing facility in Los Angeles, CA, which took place from February 16, 2023, through April 6, 2023.
The FDA’s decision to inspect Oceanitan, Inc. was driven by a consumer complaint, although the warning letter did not provide specific details regarding the infant botulism case. Following the inspection, the FDA issued a Form FDA 483, known as Inspectional Observations, which documented the deviations discovered during the examination of the facility.
Under the FDA’s enforcement activities, warning letters are routinely sent to entities within its jurisdiction as part of the regulatory process. It is important to note that certain letters may not be made public until several weeks or months after their issuance. Companies receiving FDA warning letters typically have a 15-day window to respond. It is common for warning letters to be issued after companies have been afforded months to years to rectify identified issues, indicating the seriousness of the regulatory concerns raised.
Now faces the task of addressing the FDA’s concerns and taking appropriate corrective actions to ensure compliance with food safety regulations. The issuance of this warning letter underscores the FDA’s commitment to safeguarding public health by upholding strict standards in food manufacturing practices and safety protocols.
