FDA EIR - Perrigo Nutritionals, LLC - September 26, 2013

This FDA Establishment Inspection Report details a high-priority inspection of Perrigo Nutritionals, LLC, located in Georgia, VT, conducted from September 23-26, 2013. The inspection was carried out under the Infant Formula Compliance Program Guidance Manual and the Domestic Food Safety Compliance Program Guidance Manual, among others, focusing on the manufacturing of powdered infant formulas. Crucially, the inspection concluded with no issuance of an FDA Form 483 (Inspectional Observations), indicating no objectionable conditions or significant violations were identified. The firm had previously corrected an observation regarding a lack of backflow prevention devices noted in an earlier inspection. During this review, various aspects of the facility were assessed, including Good Manufacturing Practices, pest control, audit programs, and production records for DHA milk-based formula, which were found to be within specifications. The report also addressed several consumer complaints, including those about "black specks" and "dark particles" in formula, and one serious adverse event report. In all cases, Perrigo Nutritionals, LLC's investigations determined the products were within specifications, and no health risks or systemic issues were confirmed. No recalls or market withdrawals were ongoing or initiated in the preceding year. Samples were collected for microbiological and nutrient analysis, but no immediate corrective actions were mandated as a direct result of this inspection.