FDA 483 - NHS U.S., LLC - September 05, 2008

This FDA Form 483 document outlines observations made during an inspection of a dietary supplement manufacturing facility. The inspection revealed three key violations related to documentation, record-keeping, and personnel hygiene.

Firstly, the facility failed to maintain adequate documentation for the cleaning and sanitizing of equipment used in preparing coating solutions for dietary supplement tablets. The cleaning log for the Solution Prep Room showed the last entry by an operator on July 26, 2008, despite coating solutions being routinely prepared in this room after that date, including as recently as August 27, 2008, for Lot #231969.

Secondly, batch production records were found to be incomplete. Specifically, the Raw Material Dispensing Sheets used for monitoring raw materials in the Weigh Room did not include the actual results obtained during monitoring operations. This included the omission of each partial raw material weight and the identification of the equipment used.

Finally, personnel did not consistently adhere to hygienic practices necessary to protect against contamination of dietary supplement ingredients. Specifically, personnel were observed not wearing outer garments in a manner that effectively protects against contamination of dietary supplement ingredients. These observations indicate deficiencies in the facility's quality system, particularly concerning documentation control, record accuracy, and personnel hygiene practices, which could have operational implications for product quality and regulatory compliance.