Company-wide Auditing for EPA and FDA Compliance

This expert consultant conducted an audit of product files for a company to ensure that their products were in complete compliance with the Toxic Substances Control Act (TSCA) under the jurisdiction of the Environmental Protection Agency (EPA) and with the regulations for food contact under the jurisdiction of the Food and Drug Administration (FDA). This process was necessary to ensure that if a government audit was requested by either EPA or FDA, their files would be in compliance.

This consultant went through the product files to determine which ones were for industrial use only and made sure that the product or that each product component was listed on the TSCA inventory for commercial sale in the US. This consultant also evaluated those products that were subject to FDA compliance regulations due to the fact that they would come in direct contact with food products either for human or pet consumption. This consultant made sure that the proper approvals were obtained for each of the products that were intended for food contact uses.

In cases where the products were in compliance, the necessary information was isolated and put it in a separate area within the file so that if the company were to be audited, the information needed would be located in the same place in each file. This consultant also made sure that current copies of Material Safety Data sheets were included in each file and that they were in the ANSI 16 section format and that standardized phrasing was utilized throughout the entire product line.

In the few cases where there was an issue of missing information, copies of the needed information were obtained to include in the product file and the current MSDS verified that it was in proper format and included in the file.

Because of the attention to detail and making sure that each file was separated into distinct sections for specific information, when the EPA came into the company about a year later for an audit, the customer had no problems with the audit and was complimented on the completeness of the files and the fact that the information was easy to locate.

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