Foreign drug inspections will generally involve bulk pharmaceutical chemicals (BPCs) or dosage forms. The end product may be sterile or non-sterile. Contract processors or contract laboratories ...
FDA Lawyer in Miami, FLorida. If you're aiming to ensure FDA compliance as you're developing a new product, your company is facing an FDA warning letter, or you're looking for clarity on what to expect in an FDA inspection, turn to Capote Law Firm.
Feb 02, 2011 · Foreign Inspections . 2. Inspectional Instructions ... The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as Current Good ... traced by the manufacturer ...
Jun 28, 2019 · House Committee Questions FDA on Foreign Drug Manufacturing Inspections. As the US Food and Drug Administration (FDA) continues to recall contaminated blood pressure drugs made in foreign facilities, the House Energy & Commerce (E&C) Committee on Friday sent a letter to acting FDA Commissioner Ned Sharpless questioning the agency’s work overseas.
FDA’s Sampling and Testing Program. Although application assessments and inspections are a foundation of FDA’s efforts to maintain a safe, reliable drug supply, the safety and effectiveness of drugs depends on a multipronged approach, of which quality checks by FDA and manufacturers are a part.
Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA or the Agency), which is part of the Department of Health and Human Services (HHS).
The SSM is at the core of FDA’s surveillance inspection prioritization program and ensures a uniform approach for domestic and foreign facility inspections. The Agency uses the model to calculate a score for every facility in its Catalog using risk-based factors. Factors in the SSM include: Inherent product risk.
(See Figure 3) FDA’s drug inspection program is now risk-based. FDA prioritizes for inspection facilities deemed higher-risk based on specific, defined criteria.
In 2019, the concurrence rate had risen to 73 percent.
FDA has performed more foreign than domestic inspections since 2015. The Agency utilizes a risk-based site selection model to identify firms for inspection. FDA has achieved this level of foreign coverage by using a mixed investigator work force consisting of (1) U.S.-based investigators who perform both domestic and foreign inspections; (2) a dedicated foreign cadre of U.S.-based drug investigators who conduct foreign inspections exclusively; and (3) foreign office-based investigators who inspect facilities manufacturing human drugs (See Table 1). The majority of foreign inspections are performed by domestically based staff in the first two categories.
FDA inspects manufacturing facilities and takes action, if needed, to enforce CGMP quality standards and applicable regulations. The Agency’s investigators look for deficiencies in meeting CGMP standards, but these assessments do not measure how far the facility is above the minimum CGMP. Simple adherence to CGMP standards does not indicate that a firm is investing in improvements or planning or deploying advanced quality control techniques that could better enable it to prevent quality problems leading to supply disruptions.
Foreign drug inspections will generally involve bulk pharmaceutical chemicals (BPCs) or dosage forms. The end product may be sterile or non-sterile. Contract processors or contract laboratories may also be assigned. The Investigators/Analysts will inspect these facilities in the same manner as domestic facilities.
Responsibility of the inspection team is to evaluate the foreign facility's compliance with cGMPs and its adherence to application commitments and DMF information, if applicable. The inspection team is expected to review background documents and records whenever possible and prepare for the inspection prior to travelling abroad. This is necessary due to the tight time-frame usually assigned to each inspection; without advance preparation, an adequate inspectional coverage cannot realistically be attained in most cases. At this stage of planning, the inspection team will have to determine tentatively those issues needing attention during the on-site inspection.
The foreign inspection program is under the management and direction of the International and Technical Operations Branch (ITOB) headquarters staff of the Division of Emergency and Investigational Operations/ORO. This branch schedules all foreign inspection trips and provides all the resources necessary for the program activities. ITOB also performs liaison activities with CDER, CVM, field offices, and the regulated industry. In addition, headquarters staff of the branch is responsible for resolving logistical difficulties that may arise during inspection scheduling, in-transit changes, and pre-inspection document support, and other issues.
ITOB headquarters staff is responsible for scheduling all foreign inspectional activities. When requests for inspection from various components of the agency are received by ITOB, it schedules and assigns inspections to foreign inspection cadre members according to their specialties and availability. Geographical factor also influences the assignment of the inspections; i.e., ITOB tries to assign inspections to the lead investigator of the home district where the sponsor firm is located. This proximity to the sponsor firm will provide the inspection team some advantage in dealing with the US representative at all stages of the inspection.
The lead Investigator is responsible for making the pre-inspection preparation and identifying the areas of focus for each member. The lead Investigator is also responsible for providing the Analyst with any records or data that need to be reviewed prior to the inspection. During the inspection, he or she leads the direction of the investigation and determines the types of records or operations to be examined by the team. However, keep in mind that the ultimate objective is to maximize the inspectional coverage by working together as a team and the role played by each team member should be flexible. In fact, the team members often need to operate independently at different locations.
Pre-approval inspections (PAIs) requested by CDER and CVM for approval of specific NDAs/ANDAs/NADAsA constitute a major segment of FDA's foreign pharmaceutical inspection activities. When a PAI inspection is scheduled at a given facility, ITOB may, at its discretion, request the inspection team also cover other product applications needing priority handling. District NDA program managers should keep track of and advise ITOB headquarters staff of any significant issues pending at the facility that must be resolved before an application can be approved even if CDER or CVM has not completed its review of the application.
The inspection team is there to make an assessment of each foreign facility on FDA's terms. Foreign firms are under no obligation to comply with the U.S. regulations except for their commitments in applications filed with the agency and/or for their desire to market their products in the U.S.A.
Lisa Capote founded Capote Law Firm, a minority, woman-owned practice, in 2006. From the beginning, her goal has been to provide creative solutions, zealous advocacy, and personal service to businesses in Miami and beyond.
Serving our clients' needs promptly and professionally is of the utmost importance at Capote Law Firm. We understand that FDA regulations can be complex, and you may have questions or concerns along the way. Don't hesitate to reach out—we'll be here to seek answers or provide reassurance.
In addition to food and drugs, the FDA regulates any goods that could have an impact on public health.
Products being sold in the U.S. must meet the standards established by the Consumer Product Safety Commission.
Foods, medical devices, cosmetics, and other products being imported to the United States must comply with required customs and borders regulations.
We have been working with Lisa for close to 7-8 years now. Normally, I would leave it like that, because just to say that we have been working that long with someone, in our line of business, is something important...
At Capote Law Firm, we believe that the key to ensuring your business's compliance with FDA regulations is to be proactive. Seeking the guidance of an experienced attorney as you work to obtain the necessary clearance to place products on the market can help you avoid costly, time-consuming interruptions to your business later on.
With regard to protecting drug quality, the FDA states that as the pharmaceutical industry has become increasingly global, the agency is "in volved in international negotiations with other nations to harmonize standards for drug quality and the data needed to approve a new drug.".
On its Web site, the CDER is described by the FDA as "America's consumer watchdog for medicine.". 9 This report describes the FDA as "one of the nation's oldest consumer protection agencies.". Employing approximately 1,700 physicians and other scientists, CDER is the largest of five centers organized around the FDA.
The FDA now says that the heparin problems may be the result of a counterfeit ingredient from China that was used in the drug. U.S. health officials had never inspected the Chinese factory owned by U.S.-based Scientific Protein Laboratories LLC, where some of the raw heparin ingredients were processed.
To ensure that drugs are manufactured in compliance with current good manufacturing practice regulations, FDA conducts inspections of foreign facilities that manufacture drugs for the U.S. market. At the end of an inspection, observations are made and a determination of whether any condition or practice violates Federal requirements.
The Food and Drug Administration (FDA) is responsible for overseeing the safety and effectiveness of all drugs marketed in the United States. However, FDA's oversight of the nation's drug supply chain has become increasingly complicated because many drugs used in the U.S.