FDA EIR - Brooklyn Bottling of Milton NY Inc - September 07, 2011

An FDA compliance-directed inspection of Brooklyn Bottling Co. Of Milton, NY Inc. was conducted on September 6-7, 2011. This follow-up inspection, performed under the Juice HACCP Program (CP 7303.847H) and Domestic Food Safety Program (C.P. 7303.803), aimed to verify the firm's corrective actions regarding previously identified issues. A May 2011 inspection revealed several violations, including the company manufacturing apple juice without declaring all ingredients and mislabeling products as "fresh pressed, not from concentrate" despite containing apple juice concentrate sourced from China. Additionally, floors in juice processing areas were in disrepair, and an estimated $25,000 worth of misbranded apple juice was found in stock. During the September 2011 inspection, significant corrective actions were observed. The company had revised its apple juice labels to include previously missing ingredients such as filtered water, malic acid, and apple juice concentrate. No mislabeled "fresh pressed" apple juice products were found in stock; all such cases had been sold. The firm voluntarily destroyed product labels that failed to declare all ingredients, valued at $5,000. Management also confirmed that the company is now exclusively producing apple juice from concentrate. However, management declined to issue a voluntary recall for the previously mislabeled "fresh pressed" juice, asserting there was no health hazard. Test results for a specific ingredient were also promised to the FDA. Given the observed corrective measures, no FDA Form 483 was issued at the conclusion of this inspection, indicating that the immediate concerns had been addressed.