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FDA Inspections

FDA Inspections. IMDMC Reg.101 August 19, 2014 Lynn C. Tyler Barnes & Thornburg LLP. FDA Inspections - Statutory Authority. Section 704, 21 U.S.C. § 374; 21 U.S.C. § 360(h) Reasonableness of the inspection (time, limits, manner) Consent unnecessary Search warrant unnecessary

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FDA Inspections

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  1. FDA Inspections IMDMC Reg.101 August 19, 2014 Lynn C. Tyler Barnes & Thornburg LLP

  2. FDA Inspections - Statutory Authority • Section 704, 21 U.S.C. § 374; 21 U.S.C. § 360(h) • Reasonableness of the inspection (time, limits, manner) • Consent unnecessary • Search warrant unnecessary • Miranda warnings unnecessary • Inspection warrants

  3. Prohibited Acts • Refusal to permit entry or inspection • Refusal to permit access to or copying of records

  4. Warrants • Most firms do not request a warrant • Marshall v. Barlow’s Inc., 436 U.S. 307 (1978). • Required OSHA inspector to obtain warrant but noted that warrantless inspections are permitted in “pervasively” regulated industries

  5. Warrants • A search and seizure warrant is not based on § 704. A search and seizure warrant is based on probable cause to believe that a crime is being committed and the authority to search would be much broader.

  6. Investigators • Officers or employees duly designated & trained • Presenting appropriate credentials (badge) • Written notice (Form 482)

  7. Criminal Investigator • An FDA employee • Trained for criminal investigations work • Carries a badge and gun • Will present: • Notice of Inspection or • Search Warrant

  8. Reasons for FDA Administrative Inspections • Routine • For cause • Follow up to Warning Letter or Enforcement Action • Complaints from consumers, competitors, and current or former employees • Recall effectiveness check • Pre-Approval Inspection • Special Enforcement Initiative

  9. Scope of Inspection • Scope of FDA Inspections • The scope of the inspection depends on “the information desired, or upon the violations suspected or likely to be encountered.”

  10. Scope of Inspection (continued) • FDA authority to inspect • No general subpoena authority, but in certain civil proceedings FDA may issue a subpoena for production of evidence and records. • If FDA initiates an enforcement action, records are available under the rules of discovery. • During a criminal investigation, DOJ can subpoena records relevant to an ongoing grand jury investigation.

  11. Taking of Samples • Sections 702(a) and 704(c) (21 U.S.C. § 372(a) and 374(c)) authorize the inspector to obtain samples, and prior to leaving the premises, he shall give the owner a receipt describing the samples obtained. • You may request the inspector pay fair value for the samples taken. U.S. v. Roux Labs., 456 F. Supp. 973 (M.D. Fla. 1978). (Most don’t) • Section 702(b) states that FDA shall, upon request, provide a part of such official sample to the owner.

  12. Scope of inspection (continued) FDA may inspect and copy: • records, files, papers, processes, controls and documents related to a facility bearing on whether products are adulterated, misbranded, or otherwise violative.

  13. Scope of Inspection (continued) • What FDA is not expressly authorized to obtain, but may attempt to obtain • In-plant photographs • Not specifically authorized • Dow Chemical Co. • Acri Wholesale Grocery Co. • Affidavits from individuals • Interview of employees • FDCA does not expressly authorize investigators to interview a company’s employees; with/without company’s counsel: • Managerial employees • Non-managerial employees

  14. Cases • Dow Chemical Co. v. United States, 476 U.S. 227 (1986). • Court upheld EPA’s right to take aerial photographs after company refused request for on-site inspection. • United States v. Acri Wholesale Grocery Co., 409 F. Supp. 529 (S.D. Iowa 1976). • FDA argues the case authorizes photographs. • FDA’s Inspection Operations Manual (IOM) includes a section that requires inspector to explain FDA’s authority to take photographs

  15. Limits on Inspection • FDA Authority to Inspect • FDA may not inspect: • Sales data other than shipping figures. • Pricing data. • Personnel data other than information establishing the qualifications of technical and professional personnel. • Certain research data except to the extent such information may be required to be made available for inspection or submitted to FDA for particular products. • Management reviews • Internal audits

  16. Procedure for Conducting Inspections • Investigation Operations Manual (www.fda.gov/ora/inspect_ref/iom/IOMTC.html) • Present Credentials and Notice of Inspection • Inspectional Observations (Form FDA 483) • Discussion with Management • Establishment Inspection Report

  17. Procedure for Conducting Inspections (continued) • How FDA prepares for inspections • Review of FDA inspection procedures and compliance policy guides. • Review of a firm’s most recent Establishment Inspection Reports (EIRs) and responses to 483s and warning letters.

  18. Procedure for Conducting Inspections How FDA prepares for inspections • Selection of team and designation of team leader • The team leader: • Plans the inspection • Schedules and coordinates team member pre-inspection preparations • Assesses progress of the inspection • Coordinates preparation of investigation reports

  19. Procedure for Inspection Pre-Approval Inspections • CDER/CDRH’s Role • Review data in application(s) • Establish specifications for manufacture and control based on data

  20. Procedure for Inspections Pre-Approval Inspections • Districts’ Role: • Assure cGMP compliance • “Data audit” – verify authenticity and accuracy of data submitted • Report other data or information with impact on cGMP compliance • Verify compliance with application commitments

  21. Procedure for Inspection (continued) Pre-Approval Inspections • Inspection Teams (Investigators, Analysts, Engineers, etc.) • Areas Covered: • Manufacturing (GMP) • Reprocessing (if in application) • Laboratory (Equipment and Procedures qualified and validated, raw data) • Components • Buildings and Facilities (impact on other products, structure) • Equipment (cleaning validated) • Packaging and Labeling Controls (accountability, past mix-ups, recalls) • Process Validation (including pre-approval and commercial batches)

  22. Scope of Inspection (continued) Pre-Approval Inspections: • Field Recommendations: • Approve (NAI, VAI) • Withheld approval (OAI – with reasons why) • Delay approval pending pre-approval inspection • “Show Stoppers” • Application misrepresents data • Inconsistencies and/or discrepancies raising significant questions about the validity of records • Pre-approval samples not made in cGMP compliance • Failure to report adverse findings or test data without adequate justification

  23. Procedure for Conducting Inspections (continued) What to do before an inspection • Evaluate relationship with FDA • Inspection policy • Assess systems, procedures, and controls • Review company performance • Establish team & plan

  24. Procedure for Conducting Inspections (continued) What to do during an inspection: • The Team Approach • The daily record • Entry and observation: What is allowed • Access to documents • Types of documents • Reasonable access • Provide what is requested • Keep good records; keep copies

  25. Procedure for Conducting Inspections (continued) Closing the inspection • The Exit Meeting - a critical part of the inspection • Presentation of Form FDA 483 – written report of the Inspection Observations • Discussion of a reply

  26. Procedure for Conducting Inspections (continued) After the inspection • Report to Regulatory Affairs and Senior Management • Response to Form FDA 483 is critical • Provide tangible evidence that you are correcting problems • Allocate necessary resources to make corrections • Address major quality system or safety issues first • Demonstrate that you understand issues and what corrections are necessary • Follow-Up

  27. Inspections • Upon completion of inspection and prior to leaving the premises, the officer making the inspection shall give a report in writing setting forth any conditions or practices which indicate • any filthy substance, or • unsanitary conditions (violations of statute or regulations) • Receipt for sample • Copy of results of analysis shall be furnished promptly, if requested

  28. Establishment Inspection Reports • Establishment Inspection Report (EIR) – • report written by the investigators that summarizes all the findings from the inspection. • Investigators submit EIR to the District Office for a classification decision

  29. Establishment Inspection ReportsDistrict Classifications • No Action Indicated (NAI) • No objectionable conditions or practices were found during the inspection (or the significance of the documented objectionable conditions found does not justify further action). • Voluntary Action Indicated (VAI) • Objectionable conditions were found and documented but the District and/or Center is not prepared to take or recommend any of the regulatory (advisory, administrative, or judicial) actions listed below since the objectionable conditions do not meet the threshold for regulatory action. • The district may use an Untitled Letter, Regulatory Meeting or other communication with responsible individuals to inform the establishment of findings that should be corrected. • A written response by the establishment may be an option, but is not necessary. • Any corrective action is left to the establishment to take voluntarily. • Official Action Indicated (OAI) • Objectionable conditions were found and one of the regulatory actions listed below should be recommended. • Includes voluntary recalls where the district has decided conditions warrant regulatory (advisory, administrative, or judicial) action. • Typically, an OAI classification should be made only if a FDA-483 has been issued and the documented evidence supports the action recommended.

  30. Establishment Inspection ReportsDistrict Classifications (continued) • Referred to State (RTS) • Referred to State, local, or other federal office. • This classification can be used only when either there is no federal jurisdiction over the apparent violation in question or it is determined that State action is the most efficient method of obtaining the establishment’s compliance with applicable Federal Laws, Regulations or Administrative requirements. • Referred to Center (RTC) • This “District Decision Type” can only be used when the objectionable conditions or apparent violations noted constitute a compliance area for which no clear policy has been established or significant technical issues exist which require Center review and decision. • An RTC classification should be made only if a FDA-483 has been issued.

  31. Considerations for Inspection Policy • Procedure upon inspectors’ arrival • Ask for credentials • Ask to see Form 482 (Notice of Inspection) • Advise of policies (goggles, lab coats, shoe covers, etc.) • Designated representative • Trained • Back-up • No free-roaming • Advise of policies (interviews, etc. below) • Reasonable time, place, manner? • Documents • No personnel files (separate file for qualifications) • No cost/pricing • No internal audits • No management reviews

  32. Considerations for Inspection Policy (continued) • Interviews? • Photographs? • Samples • Ask for receipt • Get your own sample • Ask for copy of any analysis • Affidavits or statements • Don’t read or sign • State must review with counsel

  33. Considerations for Inspection Policy (continued) • Form 483 • Discuss to understand • State disagreement, if any, with observations • Request copy • Immediately send to counsel • Respond timely (15 days), thoroughly, positively • EIR • Request copy • Immediately send to counsel

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