 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, Inc. 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, Inc. 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:
- Date of collection
- Identity of the sampler
- Size and description of lot
- Size and method of collection
Certified Laboratories, Inc. 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, Inc. contains a minimum of the following:
- Documentation associated with the sampler must be on file with FDA
- Properly signed & dated worksheets that include:
- Calculations and results
- Methods used and any modifications, instrumentation, calibrations, and conditions.
- Sample preparations and any modifications
- Any other necessary information
- Source, preparation and purity of standards
- All chromatograms or spectra
|
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:
- A list of equipment used for conducting the analysis
- A list of each type of analysis and imported commodity handled by the laboratory
- Appropriate laboratory information bulletins (LIB's)
- Cirricula vitae of personnel
- Updated and accurate quality control records
- Updated compendia if the latest official methodologies (AOAC, BAM, etc.)
TYPES OF ANALYSIS PERFORMED
- Chromatographic Analysis employing TLC, GC and HPLC, which include:
Color
Coumarin
Indole
Pesticides
Sweeteners
- Extraneous Material Analysis which include:
Feather Barbules
Fragment Counting
Hair Identification
Insect Identification
- Microbiological Analysis which include:
Coliform Count
E. coli
Enteropathogenic E. coli
Listeria Monocytogenes
Salmonella
Staphylococcus
Total Plate Count
Vibrio Cholerae
Vibrio p-Haemolyticus
- Organoleptic Examination for Decomposition on:
Canned Crabmeat
Canned Tuna
Fresh Fin Fish
Froglegs
Frozen Fin Fish
Lobster
Octopus
Scallops
Shrimp
Squid
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, Inc. 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
We believe that Certified Laboratories, Inc. 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.
SAMPLING
Sampling of your product can sometimes be a problem, Certified Laboratories, Inc. is familiar with all FDA sampling schedules. We have a staff of trained samplers who can handle the complete sampling procedure or, if you prefer to submit the sample yourself, we will explain to your personnel the proper sampling plans to employ. We are always prepared to take responsibility for sampling at the following ports:
BOSTON
NEW YORK / NEW JERSEY
PHILADELPHIA
LOS ANGELES
SAN FRANCISCO
TAMPA
MIAMI
OTHERS BY REQUEST |
|
