> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Drug Inspection Teams Asking Reviewers’ Questions: Complaint
- URL: https://www.fdaweb.com/drug-inspection-teams-asking-reviewers-questions-complaint/
- Published: 2016-07-21T12:00:00.000Z
- Updated: 2026-09-14T21:16:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136243

Now that CDER reviewers are accompanying ORA investigators as part of the drug preapproval inspection team, some of the questions being asked during the inspections are seeking answers to issues typically communicated in NDA/BLA/ANDA review “information request” letters. This was a complaint raised during a Pharmaceutical Quality Symposium webcast 7/20 by an attendee trying to understand the focus of the Integrated Quality Assessment (IQA) team under CDER’s Office of Pharmaceutical Quality (OPQ).

The attendee observed that answers to these types of questions were being noted on Form 483s or the Establishment Inspection Reports as deficiencies. Additionally, he said companies are feeling pressured to answer these information requests on the spot instead of having time to assess them and to evaluate what is going on and the impact on the submission package.

OPQ Office of Process and Facilities acting director **Bob Iser** acknowledged that more training is needed for reviewers who are new to the inspection teams, “so hopefully there will be less of that going on.” He said it is best to be “open and transparent when the inspection team is at a facility about questions we may have. There may be questions that we have that are much more appropriate to come through the information request route and not be something that is listed on 483s or inspection reports. There may be things there that are discussion topics that we would then follow up to say ‘submit this as an information request,’ which is in many cases more appropriate than putting it in a 483 so that it goes through a different review route when it gets to us... Now, if there is a question and it is something that you can answer, there is always a benefit to being transparent and answering that. There could be questions based on something we saw in the submission because preapproval inspection coverage is also planned to verify or confirm things that are in the submission. So there are some gray areas in these situations.”

According to previous CDER [guidance](http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm172134.pdf?ref=fdaweb.com), an information request letter should be sent to an applicant during an application review to request further information or clarification that is needed or would be helpful to allow completion of the discipline review. FDA reviews industry responses (if they are of a clarifying nature) as part of the current review cycle of the application. “However, if the response is of a significant nature, the response could constitute a major amendment,” the guidance says. Major amendments to an original application received in a review’s last three months may extend the action due date by three months, it adds.

OPQ director **Michael Kopcha** told the symposium that his office is still advancing the “quality metrics” initiative. Staff are reviewing recent comments submitted by industry and they are “determining how best to address those.” Last year, FDA released a [draft guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM455957.pdf?ref=fdaweb.com) on “Request for Quality Metrics” that outlined the data it plans to request from pharmaceutical and biologic manufacturers as part of the risk-based inspection program. It expects that quality metrics calculated from data that it collects will provide objective measures that, when used with additional internal data, will provide the agency with indicators on the effectiveness of pharmaceutical manufacturing quality systems. CDER has said that quality metrics will be input into its compliance database to inform “our understanding of the overall quality across the industry, and identify the outliers to set our inspection priorities. We've had a risk model that we have used for many years and we want to get up several levels in sophistication on that model and have real-time data feeding into that to assess the highest risk facilities.”

Earlier this year, Pharmaceutical Research and Manufacturers of America (PhRMA) weighed in and said FDA should provide transparency on how it plans to process, interpret, and use the quality metrics data ([see story](http://www.fdaweb.com/login.php?sa=v&aid=D5135098&searchWords=quality%20metrics&cate=S&stid=%241%24aT0.b22.%24Wnx1JzHr8S4RJ8xadvzAz0)). The association also asked FDA to clarify that it will continue to protect manufacturers’ confidential commercial information when it collects such data. Additionally, it called on FDA to phase-in the program to make it possible to incorporate lessons learned by stakeholders over time.

Kopcha also touched on OPQ’s new inspection protocol project (NIPP), which is intended to provide a better approach to monitor quality. He told attendees that the quality-focused, semi-quantitative approach will use streamlined and structured inspection templates. “So when inspectors go out to a site, it will be more standardized in terms of their inspection so companies know what that inspection will look like,” he explained. “So there should be a clearer understanding of what we will be looking for when we come in to do an inspection.”

OPQ has previously said that NIPP protocols will utilize expert investigator questions and assessment approaches. NIPP is expected to increase the quality focus of investigator assessments, so that facilities and behaviors found to exceed basic compliance can be recognized as such. Following successful piloting, NIPP-developed protocols will be incorporated into new mobile technology to capture investigator findings and assessments and better support investigators while traveling and during facility inspections.