Article: Regulations: FDA: New Post-inspection Response -- October 2009
In a recent Federal Register (August 11, 2009) (74 FR 153 pages 40211-40212), the Food and Drug Administration (FDA) published its Notice, which, depending upon an inspected facility’s current practice for handling Form 483 Observations, could significantly affect how facilities respond to such inspectional observations.
Observational Reports
If, during an inspection, an investigator notes “significant objectionable conditions,” he or she is to close the inspection by leaving management with a Form FDA 483--Inspectional Observations. Observations are to be made and noted, when, “in the investigator’s ‘judgment,’ conditions or practices observed indicate that any food, drug, device or cosmetic have been adulterated or are being prepared, packed or held under conditions whereby they may become adulterated or rendered injurious to health.” Institute of Medicine (IOM) 5.2.3.
Under IOM 5.2.3.1.4, inspected establishments are to be advised that “(these) are inspectional observations, and do not represent a final Agency determination regarding your compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or action with the FDA representative(s) during the inspection or submit this information to FDA at the address above.” However, neither the IOM nor the FDA 483 specify the period of time within which such response or corrective actions are to be undertaken.
15 Days to Respond
Pursuant to the Notice and beginning September 15, 2009, establishments will have 15 days in which to respond to the observations. FDA will review the establishment’s response as part of its determination process in whether or not to issue a Warning Letter. FDA, in its Warning Letter, will comment on the “apparent adequacy” of the proposed corrective actions. No time limit is stated for issuance of a Warning Letter based upon a response received within 15 days, but FDA expects inspected establishments to “implement needed corrections regardless.”
If a response is received outside the 15-day window, FDA will not comment on any corrective actions undertaken, but rather will regard the tardy response as the inspected facility’s formal response to the Warning Letter, along with any later delivered materials.
Establishments should revisit their internal protocols for handling inspections, be prepared to closely record and monitor observations, and be prepared to make a timely response to any FDA 483 Observations made by an FDA investigator.
Update: Acrylamide in Food
Identifying acrylamide as “a chemical that can form in some foods during certain types of high-temperature cooking”...that “has been found to be carcinogenic in rodents and is, therefore, considered a potential carcinogen in humans,” in the August 26 Federal Register (74 FR 43134), the FDA published a Notice seeking “comments and scientific data and information on acrylamide in food.” The Notice stated that acrylamide occurs most often in “plant-based foods, notably potato products…coffee; and cereal-grain-based foods...” The information requested came in a series of specific questions, headed by categories of “Methods of Reducing Acrylamide Levels in Food” and “Levels of Acrylamide in Food.” Based upon the information received in response to the Notice, “FDA is considering issuing guidance for industry on reduction of acrylamide levels in food products.” Interested parties have until November 24, 2009, to submit comments. pf
Mark Hostetler is an attorney at Husch Blackwell Sanders LLP. Experienced in advising consumer product companies and focusing primarily in the food industry, he has guided producers, advertisers and marketers through regulatory proceedings, product recalls, new product introductions, and new advertising and promotional campaigns. He can be reached at Mark.Hostetler@huschblackwell.com.
Observational Reports
If, during an inspection, an investigator notes “significant objectionable conditions,” he or she is to close the inspection by leaving management with a Form FDA 483--Inspectional Observations. Observations are to be made and noted, when, “in the investigator’s ‘judgment,’ conditions or practices observed indicate that any food, drug, device or cosmetic have been adulterated or are being prepared, packed or held under conditions whereby they may become adulterated or rendered injurious to health.” Institute of Medicine (IOM) 5.2.3.
Under IOM 5.2.3.1.4, inspected establishments are to be advised that “(these) are inspectional observations, and do not represent a final Agency determination regarding your compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or action with the FDA representative(s) during the inspection or submit this information to FDA at the address above.” However, neither the IOM nor the FDA 483 specify the period of time within which such response or corrective actions are to be undertaken.
15 Days to Respond
Pursuant to the Notice and beginning September 15, 2009, establishments will have 15 days in which to respond to the observations. FDA will review the establishment’s response as part of its determination process in whether or not to issue a Warning Letter. FDA, in its Warning Letter, will comment on the “apparent adequacy” of the proposed corrective actions. No time limit is stated for issuance of a Warning Letter based upon a response received within 15 days, but FDA expects inspected establishments to “implement needed corrections regardless.”
If a response is received outside the 15-day window, FDA will not comment on any corrective actions undertaken, but rather will regard the tardy response as the inspected facility’s formal response to the Warning Letter, along with any later delivered materials.
Establishments should revisit their internal protocols for handling inspections, be prepared to closely record and monitor observations, and be prepared to make a timely response to any FDA 483 Observations made by an FDA investigator.
Update: Acrylamide in Food
Identifying acrylamide as “a chemical that can form in some foods during certain types of high-temperature cooking”...that “has been found to be carcinogenic in rodents and is, therefore, considered a potential carcinogen in humans,” in the August 26 Federal Register (74 FR 43134), the FDA published a Notice seeking “comments and scientific data and information on acrylamide in food.” The Notice stated that acrylamide occurs most often in “plant-based foods, notably potato products…coffee; and cereal-grain-based foods...” The information requested came in a series of specific questions, headed by categories of “Methods of Reducing Acrylamide Levels in Food” and “Levels of Acrylamide in Food.” Based upon the information received in response to the Notice, “FDA is considering issuing guidance for industry on reduction of acrylamide levels in food products.” Interested parties have until November 24, 2009, to submit comments. pf
Mark Hostetler is an attorney at Husch Blackwell Sanders LLP. Experienced in advising consumer product companies and focusing primarily in the food industry, he has guided producers, advertisers and marketers through regulatory proceedings, product recalls, new product introductions, and new advertising and promotional campaigns. He can be reached at Mark.Hostetler@huschblackwell.com.
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