FDA Expands Inspection Guidance to Apply to Device Manufacturers | Sheppard Mullin Richter & Hampton LLP

On December 15, the US Food and Drug Administration (FDA) issued a draft guideline, titled “Methods That Delay, Delay, Limit, or Eliminate Drug Inspection or Inspection” (the “Inspection Indicator Guide”), which explains the types. of conduct that the FDA considers delaying, denying, limiting, or resisting participation in an investigation, each of which constitutes adulteration of a drug or device under the Federal Food, Drug, and Cosmetic Act (FDCA).[1] The Inspection Draft Guidance clarifies certain behaviors described in FDA’s previous guidance on the subject (the “2014 Guidance”) and, most importantly, expands the previous guidance to apply to medical device manufacturers.

What’s New in the Survey Draft Guide?

The most popular feature of the Screen Draft Guide is new to device manufacturers; The 2014 Guidelines applied only to drug manufacturers.

The Investigation Draft Guide also provides additional examples of behaviors that warrant delay, denial, reduction, or refusal to participate in an investigation or a reasonable explanation. The new models are as follows:

  • The FDA might think so delays during inspection are unacceptable if a facility agrees to a pre-announced inspection date, but when the inspector enters the facility, appropriate facility personnel are not available, or the facility manager notifies the inspector that the facility is closed actions, without proper explanation;
  • The FDA might think so a delay in the inspection period is allowed if the facility does not allow the FDA inspector access to environmentally controlled areas until the inspector meets the facility’s precautionary measures to prevent contamination and risk to personal safety ;
  • The FDA might think so delays in producing records are acceptable if the requested records are stored off-site and require additional collection time;
  • The FDA might think so there is a requirement to enter an entry that is not allowed if the firm interrupts manufacturing operations to prevent FDA inspectors from observing manufacturing operations;
  • The FDA might think so restrictions on photography are accepted if the facility can document that taking photos of a raw material or event will adversely affect the quality of the products;
  • The FDA might think so restrictions on records are not allowed if a facility identifies an electronic record as an original but does not provide an electronic copy of that record to FDA upon FDA’s request; a
  • The FDA might think so restrictions on records are not allowed If a facility maintains electronic records but omits or restricts the data contained in the electronic records when providing electronic copies of the records to the FDA, including actions such as removing in the data columns in the table, extracting data from the electronic record when providing the record to the FDA. , exporting data into reports without entering all data fields (unless otherwise required by FDA), or closing the electronic worksheet so that it is not searchable, indexable, or analysis by the FDA.
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As in the 2014 Guidance, the Inspection Draft Guidance explains that FDA broadly interprets the terms “delay,” “deny,” “limit,” and “deny entry or inspection ,” and warned that it would be considered a “promotion” if a company refused, blocked, delayed or failed to participate.

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Once the FDA finalizes the Inspection Drug Guide, medical device manufacturers will be subject to the principles and recommendations outlined in the guide. Medical device manufacturers should be prepared to incorporate the principles in the Inspection Draft Guide into manufacturing site policies and standard operating procedures.

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[1] Check it out 21 USC § 351(j).

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