Preparation for FDA Regulatory Inspection (21 CFR 117, FSMA)

BEC has provided FDA inspection readiness services for the last twelve years with an excellent success rate. Our expert service includes the following activities:

  • Initial gap assessment to identify opportunities areas, including comprehensive data integrity assessment
  • Development of a detailed and comprehensive remediation plan to address weak or noncompliance areas
  • Training your staff to prepare for an FDA inspection and how to interact with the inspector
  • Formal mock inspection to practice and to challenge staff and quality systems prior to the inspection
  • War-room handling/support during the inspection, with both onsite and remote expert support
  • Post-inspection support preparing formal responses and managing interactions with the FDA, including regulatory meeting preparation and support

We have extensive experience helping companies to address critical agency findings, as well as untitled and warning letters. We have a proven, demonstrable track record addressing complex regulatory problems and compliance issues.

Mock FDA Regulatory Inspections/FDA Readiness

We will provide your company with the best possible preparation for your next FDA inspection. After hundreds of FDA inspections, we know very well how inspections are performed, and what inspectors look for. We can even mimic the FDA inspection atmosphere when more than one inspector is expected. Our mock inspections can include one-day education on FDA readiness and how to interact with the FDA inspector. We will advise your company on what documentation needs to be ready, how to establish an effective war-room to attend the inspection and how to effectively manage all aspect of the inspection, from logistics to record-keeping.

Quality System Assessment/GMP Compliance

Our team of experienced professionals can perform a thorough, in-depth assessment of your quality system against regulatory requirements and guidances, industry best practices and other standards such as USP and ICH. Our detailed risk-based audit report will include recommendations to enhance your weaknesses and can be used as the basis for a remediation/corrective action plan.  

Often our clients request us to audit specific elements of their quality system. Some examples of this kind of audit recently audits performed are:

Data Integrity
Pest control
Incoming Process Control
Manufacturing Processes
Packaging Processes
Warehouse and Distribution Centers
Sterilization Process
QC Analytical laboratory

QC Microbiology laboratory
CAPA Systems
Change Control
Internal Audit Program
Supplier Certification Program
Training Program and Learning Verification Process
Facilities and Critical Utility Systems
Validation Program

Internal Audit/Self Inspection

The internal audit program is a regulatory requirement of the FDA and worldwide regulators. This program, when well executed, is your primary line of defense against regulatory inspection findings. However, many FDA regulated companies have weak internal audit programs. This is due to:

  • Internal auditors are inherently independent
  • Internal auditors lack the education and experience necessary in many areas such as data integrity, computer system validation, laboratory test methods, equipment validation, etc
  • Many internal audit programs are not risk-based

We established a very successful internal audit outsourcing model where we perform, twice a year, an in-depth assessment of the different elements of the applicable quality system, with a team of experts covering all the critical areas and elements. This model guarantees you a much more robust internal audit program that saves your company money. Typically you can save up to 50% of your current investment in the internal audit program.    

Supplier Control Programs

We can design, implement and/or support a risk-based efficient supplier control program. Each year, our experts perform more than one hundred third party audits worldwide. We are servicing several major global companies auditing their critical suppliers worldwide. During 2016, we audited in 15 countries, including India, China, South Korea, Japan, North America, Central and South America and Europe.   

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