FDA 483 - Abbott Laboratories - September 24, 2019

This FDA Form 483 document details an observation made during an inspection of a facility producing powdered infant formula. The core issue identified is the failure to test a representative sample of a production aggregate of powdered infant formula at the final product stage, prior to distribution, to ensure it meets required microbiological quality standards.

Specifically, on September 16, 2019, the firm was observed collecting 30 samples of Similac Pro Sensitive Batch No. (b)(4) during packaging on Packaging Line (b)(4). This quantity contradicts the firm's own internal document, Document ID: AN06-09-004, titled "Global Microbiological Standards," effective June 26, 2019. Page 27 of 41, section 5.5.6.1 of this document, explicitly states that sixty samples are to be collected for *Salmonella spp* testing. This indicates a deviation from established internal quality control procedures for microbiological testing of a critical product like infant formula.