FDA EIR - Procter & Gamble Co - April 06, 2017

An FDA inspection was conducted at Procter & Gamble Co.'s corporate headquarters and research and development center in Cincinnati, OH, on April 6, 2017. The inspection, performed under CP7356.002 (Drug Process Inspections), focused on the firm's handling of two consumer complaint reports. No objectionable issues were identified, and no FDA-483 was issued during this limited, directed inspection.

The first complaint, MSB report 2017-01188, involved Metamucil Therapy for Regularity, where a consumer reported possible foreign material resembling animal bones and fat. Procter & Gamble's investigation, which included retrieving and testing the product sample, reviewing batch records, and assessing manufacturing processes, concluded that the material was likely wet, clumped Metamucil powder. The firm found no evidence of foreign object contamination and confirmed robust manufacturing controls.

The second complaint, MSB report 2017-01806, concerned Old Spice Wild Collection Bearglove deodorant, with a consumer reporting a severe burning and itching rash. The company investigated this adverse event, examining manufacturing, packaging, and analytical records for the specific lot. While this lot had only one such complaint, Procter & Gamble acknowledged receiving 30 similar reports for this product type over the past year, which they actively track using a statistical signal detection system. Analytical testing of retain samples confirmed the active ingredient content was within specifications.

Given that no significant issues were found and the firm adequately investigated both complaints, no specific actions were required by the FDA from this inspection.