FDA 483 - BlendHouse LLC - December 11, 2023

BlendHouse LLC received an FDA Form 483 following an inspection from December 11, 2023, to January 19, 2024, at its Reading, PA facility, an infant formula manufacturer. The inspection identified three significant observations related to Current Good Manufacturing Practices (cGMPs), crucial for infant formula safety.

Firstly, the company failed to ensure all surfaces contacting infant formula ingredients and in-process materials were adequately cleaned and sanitized. Inspectors found mold inside a batch tank on September 7, 2023, which previous firm investigations linked to airborne mold. This issue was compounded by a lack of recorded internal tank inspections and prior mold findings in the same batch room area.

Secondly, the facility was not maintained in a clean and sanitary condition. An active water leak was observed at the Dryer Level roof during the inspection, part of a pattern of numerous roof leaks throughout 2023 that impacted manufacturing areas, often while infant formula was in production.

Finally, BlendHouse LLC did not effectively exclude pests. Observations included active flies in the Dryer Level (a High Hygiene Area) and a dead fly on a ledge. A pest control report confirmed the drying tower as a hub of insect activity, noting multiple entry points and gaps in various critical areas of the facility.

These observations indicate a need for BlendHouse LLC to implement robust corrective actions, including enhancing sanitation protocols for equipment, improving facility maintenance to prevent leaks, and strengthening pest exclusion measures to safeguard infant formula from contamination.