FIELD MANAGEMENT DIRECTIVE No. 147
Procedure for Release of Analytical Results Pursuant to Section 704(d) and Situations When Dealer is Voluntarily Holding Product
March 01, 2011
This Field Management Directive (FMD) provides guidance and criteria for the timely release of analytical results to the establishment from which certain samples are collected. In addition to fulfilling the requirements of 704(d), this procedure and notification process is being expanded to cover other samples of food including raw materials, in-process samples, finished products and environmental samples.
Section 704(d) requires that whenever in the course of an inspection of an establishment where food is manufactured, processed, or packed, a sample of food 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. "Unfit for food" has been used to describe foods that have an abnormal odor, abnormal color, are contained in abnormal containers (swollen cans), contaminated with pathogens, contains an undeclared allergen, etc. It has also been used for fish infested with copepods or other parasites. Any food product that may be rejected by the consumer may also be considered unfit for food purposes. 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).
In addition, FDA has determined that analytical results of environmental samples collected in food manufacturing establishments for microbiological analysis, and analytical results for food samples taken from a lot that a firm has placed on hold should be promptly conveyed to the firm inspected so that they can take action as necessary. This FMD also provides for the notification to the responsible firm when analysis of collected samples will not be performed on a lot the firm has on hold.
When food, including raw materials, in-process and finished products, or environmental samples are collected during an inspection of a food manufacturer, processor or packer, the FDA investigator will determine the manufacturer’s intent with respect to holding or distribution of the food from which the sample was collected or the food manufactured in the environment sampled while FDA does their analysis. Many firms agree to hold products pending FDA results, and in these cases it is FDA’s desire to notify the firm of our results. If there are any positive sample results, many firms destroy those products or submit to reprocessing. If the sample results are negative, firms may distribute those products after FDA’s analysis is completed and relayed to the firm. If the food is to be held by the firm pending the results of FDA analysis, a notation will be made by the Investigator/Collector in the Collection Remarks field of the Collection Report (C/R) and the sample will be coded with a Sample Flag of “Dealer Voluntarily Holding.” The FDA investigator will also request the firm holding the product to notify FDA of any subsequent change in the decision to hold or distribute the food in question.
This directive becomes effective 3/1/2011 and applies to all factory food samples as described below, collected on or after that date. When a food or environmental sample is analyzed, if the food is being held pending FDA analytical results and/or if the food is found to be unfit, i.e., laboratory classification 3 (adverse findings), a factory food report FDA Form 1551, Report of Sample Analysis is sent by the Laboratory Director or their designee to the collecting District for issuance. If no analysis is made, the Laboratory Director or their designee is responsible for verbally notifying the Compliance Branch of the collecting district and the Compliance Branch will assure the firm is notified that no analysis was conducted.
For 704(d) samples, those samples collected during the course of an inspection of an establishment where food is manufactured, processed, or packed and analyzed for filth or microbiological contamination, the collection report will identify the sample as a 704(d) sample by clicking the appropriate box on the FACTS collection report and recording in the Collection Remarks field, the name of the person who should receive the report of sample analysis or “704(d) Letter.” The analyzing laboratory will communicate the results of analysis to the collecting district per usual procedures. The analyzing laboratory will prepare the 704(d) Letter for issuance to the dealer named in the Collection Remarks field. This is the same standard practice as has been followed in the past.
When factory food samples are collected during the course of an inspection and the dealer states they will voluntarily hold products sampled or manufactured at the time of collection, the results of analysis will be communicated to firm management officials. Factory samples consist of raw materials, in-process, and/or finished products collected to demonstrate manufacturing conditions. The collection of environmental samples is also conducted to demonstrate the manufacturing conditions at the time of the inspection. After sample collection, a "Factory Food Sample" flag must be applied to the Collection Report (C/R), as described in IOM section 126.96.36.199.5. Samples should also be flagged as “Dealer Voluntarily Holding” and the time period the products will be held included in the flag remark. The name, title and telephone/fax number of the responsible person at the firm who should be notified of FDA results of analysis should be included in Collection Remarks so the analytical results can be relayed to him/her. The analyzing laboratory should be notified of the sample shipment in advance of their receipt of the sample. This is of particular concern for environmental and highly perishable food samples as analysis must be initiated within 24 hours of collection. The laboratory should also be made aware at this time that the dealer is voluntarily holding product pending the analytical results.
Upon completion of testing, a sample summary report is generated in FACTS. If the firm has agreed to hold products pending FDA results or if the analytical results are laboratory classification 3, the Laboratory Director or their designee shall email the results of analysis to the collecting district’s established email account for receipt of analytical results. These accounts will be named following the naming convention of: “ORA <District> Sample Results.” Factory Food Letters may also be issued upon the inspected firm’s request in these instances. Form FDA 1551 can be used for this purpose and is found on the FDA Forms page on the Intranet at the following url: http://inside.fda.gov:9003/downloads/Administrative/Forms/FDA/UCM017243.pdf
The results of analysis should be received by the collecting district within 2 working days of laboratory management’s completion of the Sample Summary or FDA-465. It is the responsibility of the collecting district’s Director of Compliance or designee to promptly communicate the receipt of the analytical results within the district office to all involved parties, such as the Director, Investigations Branch and District Director. The District is responsible for promptly communicating all positive and negative sample results when a firm agrees to hold products pending FDA analysis. See also DDFI Bulletin #30 (URL: http://inside.fda.gov:9003/downloads/PolicyProcedures/GuidanceRegulations/FieldInvestigations/UCM046269.doc). The district will first call the firm management for result reporting and can use discretion whether to follow-up with an e-mailed or faxed pdf version of the report of analysis or, if used, the original signed Report of Analysis to firm management. If no analysis is made, the laboratory director or their designee is responsible for verbally notifying the Compliance Branch of the collecting district and the district will notify the firm that no analysis was conducted. It is important for each district to establish a procedure that includes the district membership in the email account, the responsible party(ies) for contacting firm management and the method of contact.
Per Laboratory Procedures Manual Volume II – Reporting Laboratory Data ORA-LAB.5.10, the sample description in the Factory Food 704(d) Letter includes the following:
- The nature of the sample, number and size of the units examined, and the code marks of the subdivisions examined.
- The results of analysis described in simple (lay) terms whenever possible, and restricted to addressing filth, decomposition or other factors causing the food to be unfit for food. Details should be given regarding any factors in the analysis that are significant in terms of the possible violation. A general summary should be provided on factors that are not significant.
- Factory food letters shall not list the analytical methods employed, conclusions drawn from the analysis, any details regarding the manner in which the sample was handled prior to the analysis, explanation of the type of examination made, or the results of examinations for factors other than filth, decomposition, or those causing the food to be unfit for food. These letters shall only be mailed to the owner or manufacturer, processor or packer from whom the sample was collected.
|Distribution:||Regional Food and Drug Directors, District Directors,|
|Laboratory Directors and Headquarter Office Directors|
|Issued by:||ORA/ORO/Division of Domestic Field Investigations|
|Publication Date:||March 2011|