The Use of Private Laboratories by Importers
BACKGROUND
The Food and Drug Administration (FDA) has for many years recognized the role of private testing laboratories in determining the quality of foodstuffs imported into the United States. Programs such as automatic detentions ("blocklisting") have resulted in the expanded use of private laboratories by importers. FDA believes that, given agency resource limitations and increasing import obligations, they are obligated to rely to a significant degree on data generated by private laboratories to make compliance decisions. Certified Laboratories has been in the forefront among laboratories in dealing with the Food and Drug Administration and working with their programs, not only on automatic detentions but other matters such as referee samples and reconditioning proposals as well.
Because we provide our results to many of the FDA districts throughout the United States we have developed uniform and effective laboratory reporting formats that are uniformly accepted by the agency.
The role of private laboratories and their use by importers is outlined in the Regulatory Procedures Manual (X9-52-1). We at Certified Laboratories adhere to those guidelines as well as to all good laboratory practices. For your information we have provided an overview of some of the requirements and procedures that we follow to assure rapid review and acceptance of our reports by FDA Districts.
SAMPLE COLLECTION
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
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Certified Laboratories uses and provides for its clients a sample collection report that meets and exceeds all these requirements. If you would like a copy, please call.
ANALYTICAL PACKAGES
All reports submitted to the Food and Drug Administration by Certified Laboratories contains a minimum the following:
  • documentation associated with the sample
  • rmust be on file with FDA
  • properly signed & dated worksheets that include:
    1. sample preparation and any modifications
    2. method used and any modifications, instrumentation, calibration and conditions
    3. calculations and results
  • any other necessary informationsource, preparation and purity of standards
  • all chromatograms or spectra
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OTHER REQUIREMENTS
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 all 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 laboratory information bulletins (LIB's)
  • updated compendia of the latest official methodologies (AOAC, BAM, etc.)
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TYPES OF ANALYSIS PERFORMED
Extraneous Material Analysis which include:
  • Hair Identification
  • Insect Identification
  • Fragment Counting
  • Feather Barbules
Microbiological Analysis which include:
  • Total Plate Count
  • Coliform Count
  • E. coli
  • Enteropathogenic E. coli
  • Staphylococcus
  • Salmonella
  • Listeria Monocytogenes
  • Vibrio p-Haemolyticus
  • Vibrio Cholerae
Chromatographic Analysis employing TLC, GC and HPLC, which include:
  • Pesticides
  • Sweeteners
  • Coumarin
  • Indole
  • Color
Chemistry Analysis which include:
  • Optimized Monier-Williams Sulfite
  • Borates
  • Artificial Color
  • Saccharin & Cyclamates
  • Histamines
Organoleptic Examination for Decomposition on:
  • Fresh Fin Fish
  • Frozen Fin Fish
  • Shrimp
  • Lobster
  • Canned Tuna
  • Scallops
  • Octopus
  • Froglegs
  • Squid
  • Canned Crabmeat
LIBRARY
In order for any laboratory to maintain its laboratory acceptance, it must be up-to-date on all analytical and Food and Drug Administration Methodologies. For that reason, Certified Laboratories maintains an extensive library that includes, among other titles, Official Methods of the AOAC, USP, BP, AACC, and AOCS, as well as FDA Bacteriological and Pesticide Analytical Manuals (BAM and PAM). In addition we keep
  • Laboratory Information Bulletins (LIB's)
  • Macroanalytical Procedures Manual
  • Current Journals including JAOAC, Journal of Agriculture and Food, Journal of Food Science
  • Import Alerts.
  • Inspection Operations Manual.
  • Compliance Policy Guide.
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We believe that Certified Laboratories is in the forefront of laboratories whose work is routinely submitted to the Food and Drug Administration to aid in the clearing of entries. We believe we have developed a reputation and expertise in this area that is second to none. We would welcome your comments and inquiries and look forward to being of service to you in the immediate future. If you require further assistance or need any answers, please do not hesitate to call us at 1-800-CERT-LAB.
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