The FDA regulates the importation of food products into the United States. Its role is to govern the quality and its subsequent safety for human and animal consumption. Eurofins Central Analytical is a member of ACIL and remains at the forefront of testing capabilities, and we have a long working relationship with the FDA. Our company has set in place several FDA testing suites; some examples include melamine, drug residues and pesticides. The fast and efficient response to such crises, while working with the FDA, has provided us with cutting edge techniques and methods accepted around the world by many international facilities.
Detainment of suspect produce has made private laboratory testing an integral part of the FDA s work. Our portside location, professional staff and state of the art facilities, make us a valuable partner to FDA. By working closely with the FDA throughout the United States, Eurofins Central Analytical has established an efficient and consistent reporting format for FDA agency acceptance.
Eurofins Central Analytical complies with all the guidelines set forth in the Private Laboratory standards section of the Regulatory Procedures Manual in area (X9-52-1).
For your convenience we have provided information regarding the requirements and procedures that we adhere to in order to assure fast review and acceptance of our findings by the FDA.
The appropriate and representative sampling of a product is crucial in assuring that the analytical work is accurate. It is necessary that the sampling collection be documented with the following data:
- Size and description of lot
- Size and method of collection
- Identity of the sampler
- Date of collection
All reports submitted to the Food and Drug Administration by Eurofins Central Analytical Laboratories contain documentation associated with the sampler. This information must be on file with FDA, be properly signed, and include dated worksheets that cover:
- Sample preparations and any modifications
- Methods used and any modifications, instrumentation, calibrations, and conditions.
- Calculations and results
- Any other necessary information
- Source, preparation and purity of standards
- All chromatograms or spectra
To aid the Food and Drug Administration in evaluating the quality of our work and to help them in assuring the accuracy, validity and reliability of our results, we provide or make available the following:
- Curricula vitae of personnel
- A list of each type of analysis and imported commodity handled by the laboratory
- A list of equipment used for conducting the analysis
- Updated and accurate quality control records
- Appropriate FDA Laboratory Information Bulletins (LIB's)
- Updated compendia if the latest official methodologies (AOAC, BAM, etc.)
Types of Analysis Performed
Chromatographic Analysis employing GC-MS, HPLC, and LC-MSMS, which includes:
- Veterinary Drug Pesticides
- Melamine and Cyanuric Acid
Chemistry Analysis which include
In order to maintain Laboratory compliance, it is imperative that the Laboratory be up to date on all Food and Drug Administration Methodologies and Analytical Practices. Subsequently, Eurofins Central Analytical maintains an extensive library that amoung other titles, includes, Official Methods of the USP, Europeon Pharmacopoeia Protocol, AOAC, AACC, and AOCS, BP as well as FDA Bacteriological and Pesticide Analytical Manuals (BAM and PAM). We also house:
- FDA Laboratory Information Bulletins (LIB's)
- Current Journals including JAOAC, Journal of Agriculture and Food, Journal of Food Science
- FDA Compliance Policy Guide
- FDA Inspection Operations Manual
- FDA Import Alerts