FDA WARNING_LETTER - San Diego Cold Storage - April 17, 2013

On April 15-17, 2013, the FDA inspected San Diego Cold Storage, a public cold storage warehouse. The inspection and sample analyses confirmed products were adulterated under Sections 402(a)(3) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, due to rodent filth and insanitary conditions.

Investigators issued a Form FDA-483 detailing gross insanitary conditions, including: 1. Large and small rodent excreta on boxes, on and within stored raw papaya, on the floor, in floor corners, on bar rails, and alongside papaya pallets. Gaps under an exterior door were noted as a potential pest entry point. 2. Dirt and dust on ceilings and fan guards in cooling units, and an accumulation of dirt, dust, cobwebs, and debris in corners and throughout all storage areas. 3. Water dripping from a ceiling panel directly onto stored papaya in the dry goods area, with two additional ceiling leaks in another cooler.

These findings indicate inadequate cleaning and pest control. The letter acknowledges the destruction of embargoed product but recommends additional measures to prevent pest introduction. Failure to promptly correct these deviations may lead to regulatory actions like seizure or injunction. A written response detailing corrective actions and prevention steps is required within 15 working days, explaining any delays and providing timelines for completion.