What is it?

The FDA exercises authority for inspections of facilities in foreign countries which supply pharma and food products to the US. So, pharma and food plants in India that export to the US must adhere to the CGMP (current good manufacturing practices) as per FDA guidelines. FDA officials visit the facilities to check compliance with the rules.

FDA issues Form 483 at the completion of inspection. If it finds deviations from CGMP, it is mentioned in the Form 483. The form specifies areas in which the facility fell short of regulatory expectations. It is then presented and discussed with the management of the company. Along with the Form 483, the FDA also issues an Establishment Inspection Report (EIR) which specifies whether action is required to be taken.

The FDA calls for a response to the Form 483 observations within 15 working days. Though a written response is not mandatory, it is preferred so that a warning letter can be avoided. The company has to respond to the observations in detail with reasons for the shortcomings and corrective action plans. Each observation should be addressed individually.

If the management does not convincingly address the Form 483 observations within the specified time period, the FDA issues a warning letter. Sometimes, if the observations are of a severe nature, the FDA may issue a warning letter even without issuing Form 483. Unsatisfactory response to the warning letter could lead to further action including import alert for products or the facility, withholding of product approval, and suspension or cancellation of manufacturing license.

How Does a Drug or Device Manufacturer Get “FDA Approval”?

In order to receive FDA approval for a drug or a high-risk medical device, a drug’s or device’s manufacturer must prove to the FDA that the item is “safe and effective.”  Although no drug or medical device is entirely risk-free, the research and testing must show that the benefits of the drug or device for a particular condition outweigh the risks to patients of using the item.

The FDA does not do its own testing of new drugs, medical devices, or other items.  Instead, it reviews the results of clinical testing and studies performed by the item’s manufacturer.  The FDA approval process requires the manufacturer to work with the FDA during human trials of drugs and other devices to ensure trials meet rigorous scientific standards and that human subjects are protected from unnecessary risks.  The FDA uses its own statisticians, biologists, chemists, physicians, and other experts to analyze the data from the manufacturer’s clinical trials and other research.  Based on this analysis, the agency decides whether or not to approve a drug or medical device for a particular use.

 Why is it important?

 The USA is the major market for several Indian pharma companies. In the not-too-distant past, many Indian pharma companies grew strongly because of high exports to the US. In fact, Indian companies have become dominant players in the US generic drugs space. Many pharma companies in the country have made major investments in facilities with the hope of continuing export growth to the US

Role of consultant

We provide customized, value-added solutions, processes and enhanced quality standards to optimize business efficiencies and minimize regulatory risk. Our dedicated team of professionals strive to provide risk based assessments focusing on the health and welfare of the global population while minimizing the regulatory risk for our clients.

Our associates have years of experience as industry experts responsible for international Quality System Regulation/ current Good Manufacturing Practice (QSR/cGMP) inspections of pharmaceutical and medical device manufacturers, Biomedical Monitoring / Good Clinical Practice (BIMO/GCP) and Good Laboratory Practice (GLP) audits.

Services include:

• Good Manufacturing Practice (cGMP) and pre-inspection readiness audits;
• Preparation for Pre-Approval Inspections (PAI);
• Establishing Quality Assurance and Quality Control functions;
• 21 CFR Part 11and GAMP 5 implementation and audit
• IT related audit and validation support
• Risk assessment and developing Quality Risk Management Systems;
• Process Analytical Technology (PAT);
• Quality by Design (QbD);
• Process Validation;
• USFDA Audit Readiness Training;
• Preparation and Review of FDA Regulatory Submission including 510k, PMA, NDA, ANDA, IND,
• IDE, DMF, and Prior Approval Supplement (PAS) applications;
• Inspectional Observations (e.g. 483 observations) and Warning Letters responses.

Areas of Expertise:

• Quality System Implementation, Gap Analysis Audits
• Data Integrity Audits
• Third Party and Vendor Audits
• Good Clinical Practice Audits
• Risk Analysis
• Due Diligence audits
• Good Manufacturing Practice audits (Pharma/Medical Device)