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ORA FIELD MANAGEMENT
DIRECTIVE No. 147
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PURPOSE
This Field Management Directive (FMD) provides guidance and criteria for the timely release of analytical results pursuant to Section 704(d) of the FD&C Act to the establishment from which the factory food sample was collected.
BACKGROUND
Section 704(d) requires that whenever, during the course of an inspection of an establishment where food is manufactured, processed, or packaged, a food sample is obtained and analyzed for the purpose of determining whether such food consists in whole or part of any filthy, putrid, or decomposed substance, or is otherwise unfit for food, a copy of the results of such analysis shall be furnished promptly to the owner, operator, or agent in charge. These laboratory results are reported to the firm even though the investigator may have already provided the results of the field examination on form FDA-483 (List of Observations).
The term food includes all processed or manufactured foods, e.g. nutritional or medical foods, canned, medicated/non-medicated feeds. A report must issue whenever these foods are collected and analyzed for filth or any other analyte within the parameters of Section 704(d).
"Unfit for food" is to receive the same interpretation as it has historically been given in Section 402(a)(3) of the Act. The phrase has been used to describe and charge foods that have an abnormal odor, abnormal color, are contained in abnormal containers (swollen cans), etc. It has also been used in charging fish infested with copepods or other parasites. Any product that may be rejected by the consumer may also be considered unfit for food purposes.
Concern has been expressed that prompt notification of the responsible firm has not been consistently performed. In addition, this FMD is needed to clarify the issue of notification to the responsible firm when analysis of collected samples will not be performed.
SCOPE
This directive becomes effective October 1, 1997, and applies to all factory food samples collected under this provision on or after that date. If a food is analyzed, regardless of the findings, for the purpose of determining whether the food was in violation of 402(a)(3), a factory food report is sent. If no analysis is made, a designated laboratory contact is responsible for verbally notifying the firm and collecting investigator.
PROCEDURE
Factory samples consist of raw materials, in-process, and finished products collected to demonstrate manufacturing conditions. After sample collection, a "Factory Food Sample" flag must be applied to the Collection Report (C/R), as described in IOM section 439.1. The C/R must also be clearly marked as a 704(d) sample in block 38 and the name, title and telephone/fax numbers of the firm's responsible person should be included in "Remarks" so the analytical results can be relayed to him/her. The servicing laboratory should be notified of sample shipment in advance of their receipt of the sample.
When the sample summary report (FDA-465) is signed, a designated laboratory contact shall verbally notify the firm and collecting investigator of the sample results. In addition, the obligatory written notification should be sent or faxed to the firm within 3 working days of sign-off of the FDA-465.
As per Laboratory Procedures Manual section 3.5.1 (Factory Food Letters) the analytical reports on factory food samples shall provide the following descriptions:
1. The nature of the sample, the number and size of units examined, and the code marks of the subdivisions examined.
2. The findings in simple terms and, wherever possible, in lay language. For instance, instead of reporting the percentage of Class 3 cream or Class 2 fish, the percentage of decomposed cream or fish is reported.
For guidance on the interpretation of microbiological findings, please refer to the Laboratory Procedures Manual, section 3.5.1.2.
3. When reporting sanitation analyses, the appropriate phrase is "no filth found" rather than "free of filth."
The analytical reports shall not:
Details should be offered concerning any factors in the analysis when they are significant in terms of possible violation(s). Where they are not significant, a general summary may be provided. If the results are other than negative and have been forwarded for compliance review, inclusion of a contact person's name and telephone number would be appropriate in all correspondence to the responsible firm.
This page was last updated on: 05/21/99.
