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Overview
Complete
16 Nov 2018 / Pines Manufacturing / Mike Chadwick
FDA Inspection: Preparation Checklist
Inspection score
90.48%
Failed items
10
Created actions
0
Company / Facility
Pines Manufacturing
Conducted on

16th Nov, 2018

4:16 PM +08

Prepared by
Mike Chadwick
Location
6402 Torreyanna Cir, Carlsbad, CA 92011, USA
Failed items
10
Site Preparation for FDA Inspection / Administrative
Administration
To Do
Notes
WIll send final email blast after 5pm.
Site Preparation for FDA Inspection / Administrative
Reception Area Staff
To Do
Notes
We have a new receptionist that we need to remind about the FDA Inspection.
Site Preparation for FDA Inspection / Regulatory
Signature log (list of key site personnel and corresponding signatures; current and signed) (may be combined with the delegation log)
To Do
Notes
Need to check this with Marianne later.
Site Preparation for FDA Inspection / Regulatory
Master Subject Log (list of all subjects including name, contact information, enrollment and completion dates)
To Do
Site Preparation for FDA Inspection / Regulatory
Screening Log (names of all participants screened including enrollment date and reason for screen failure if applicable; ensure log is current and legible)
To Do
Site Preparation for FDA Inspection / Regulatory
Documentation of staff protocol training
To Do
Notes
Will work on this with Marianne.
Site Preparation for FDA Inspection / Regulatory
Documentation of additional staff training (if applicable)
To Do
Site Preparation for FDA Inspection / Regulatory
Signed and dated monitoring visit log
To Do
Site Preparation for FDA Inspection / Regulatory
All monitoring pre-visit letters and monitoring reports
To Do
Notes
Will double check.
Site Preparation for FDA Inspection / Laboratory
Temperature logs for applicable equipment (refrigerators, freezers, storage cabinets, etc.)
To Do
Notes
Will get a copy.
Site Preparation for FDA Inspection
10
90.48%
Administrative
2
90%
Notify all parties of impending inspection
Sponsor
Done
IRB/EC
Done
Principal Investigator
Done
Sub-Investigator(s)
Done
Study Coordinator(s)
Done
Pharmacy
Done
Laboratory(ies)
Done
Medical Records
Done
Administration
To Do
Notes
WIll send final email blast after 5pm.
Legal Counsel
Done
Reception Area Staff
To Do
Notes
We have a new receptionist that we need to remind about the FDA Inspection.
Review FDA Inspection Preparation SOP
FDA Inspection Preparation SOP
Done
Identify work space for the Inspector
Work space
Done
Telephone
Done
Copier
Done
Table
Done
Review staff and clinic schedules
Review staff schedules (vacations, appointments, miscellaneous time off, etc.) to ensure staff availability
Done
Reschedule non-essential visits/meetings if possible
Done
Clinic Equipment
Ensure temperature logs for applicable clinic equipment are complete and current (refrigerators, freezers, storage cabinets, etc.)
Done
Ensure equipment maintenance and calibration records are available and current (e.g. electronic scales, electronic blood pressure cuff, etc.) (if applicable)
Done
Regulatory
7
80.56%
Locate, compile, organize, and review documents for accuracy and completeness
List of Principal Investigator’s current active protocols
Done
Delegation log (list of personnel and delegated study responsibilities; current and signed)
Done
Signature log (list of key site personnel and corresponding signatures; current and signed) (may be combined with the delegation log)
To Do
Notes
Need to check this with Marianne later.
Master Subject Log (list of all subjects including name, contact information, enrollment and completion dates)
To Do
Screening Log (names of all participants screened including enrollment date and reason for screen failure if applicable; ensure log is current and legible)
To Do
Enrollment Log (if applicable)
Done
Randomization Log (if applicable)
Done
Protocol (all versions)
Done
Protocol amendments and clarification memorandums
Done
IRB/EC approved Informed Consent Forms (all versions including screening consent forms)
Done
Investigator’s Brochure(s) and/or Package Insert(s) (all versions)
Done
IRB/EC initial protocol approval letter
Done
IRB/EC protocol amendment(s) approval letter(s)
Done
IRB/EC continuing review approval letters
Done
IRB/EC approval letter(s) for revised Informed Consent Forms
Done
IRB/EC approval letter(s) for subject recruitment materials (advertisements, videos, handouts to participants, etc.)
Done
Evidence of EAE submission to the IRB/EC/sponsor
Done
Evidence of identification and reporting of protocol violations/deviations to the IRB/EC/sponsor per IRB/EC and protocol requirements
Done
IND Safety Reports/Memos and evidence of submission to the IRB/EC
Done
DSMB summary report(s) and documentation of submission to the IRB/EC
Done
Documentation of protocol registration submission, approval, activation, and deregistration (if applicable)
Done
All correspondence to and from the IRB/EC pertinent to the study
Done
All sponsor correspondence
Done
Any other correspondence pertinent to the study (e.g. protocol team)
Done
Form FDA 1572 (all versions)
Done
Financial Disclosure Forms (Principal Investigator and Sub-Investigators listed on the Form FDA 1572
Done
CVs (Principal Investigator, Sub-Investigators, and other key staff members; current and signed)
Done
Licenses (Principal Investigator, Sub-Investigators, and other key staff members)
Done
Good Clinical Practice/ Human Subjects Protection training documentation for individuals listed on the Form FDA 1572 and any clinical research site personnel who have more than minimal involvement with the conduct of the research
Done
Documentation of staff protocol training
To Do
Notes
Will work on this with Marianne.
Documentation of additional staff training (if applicable)
To Do
Study recruitment and retention plan
Done
Site Standard Operating Procedures
Done
Signed and dated monitoring visit log
To Do
Annual CQMP Summary Review submitted to Sponsor.
Done
All monitoring pre-visit letters and monitoring reports
To Do
Notes
Will double check.
Clinical
100%
Ensure the following has been completed for each participant
Source documents and medical records are available for each participant (Review for ALCOA) (Alternative: Source documents and corresponding Case Report Forms (CRFs) for each participant are present, clearly identified, and systematically organized in binders or folders for ease of retrieval during the inspection)
Done
Completed Case Report Forms (CRFs) on file for each participant
Done
Original signed and dated Informed Consent Forms on file for each participant
Done
Inclusion/exclusion criteria for each participant have been met and documented
Done
All visits conducted within protocol windows
Done
Correct volume of blood and correct tube type drawn at each visit
Done
Adverse Events (AEs), and Expedited Adverse Events (EAEs) have been identified and documented appropriately
Done
All EAEs have been reported to the IRB/EC
Done
All AEs and EAEs have been reported to the sponsor per study requirements
Done
Protocol endpoints have been identified and reported appropriately
Done
Ensure study product use by all participants has been documented
Done
Protocol-required tests/evaluations have been completed and documented appropriately
Done
Protocol violations/ deviations have been identified and documented appropriately
Done
Concomitant/prohibited medications have been documented and reported appropriately
Done
All laboratory reports and other diagnostic test reports are on file and display correct participant identifiers
Done
All laboratory results have been graded appropriately by the PI or designated medical officer per the DAIDS AE Grading Table and protocol-requirements
Done
Laboratory reports have been signed by the PI or designated medical officer
Done
Premature discontinuations of participants are documented appropriately per study requirements
Done
Pharmacy
100%
Locate, compile, organize, and review documents for accuracy and completeness
CV of pharmacist(s)
Done
CVs of key pharmacy personnel
Done
Licenses of pharmacy personnel
Done
Form FDA 1572
Done
Notes
I'm sure I have this will will double check,
Prescriber signature list
Done
Most recent version of the protocol for which the site has IRB/EC approval
Done
Most recent version of the protocol-specific study procedures (i.e. SSP manual)
Done
Records of study product dispensation to appropriate staff member (if applicable)
Done
Most recent version of Investigator’s Brochure(s) or Package Insert(s)
Done
CRPMC Drug Supply Statement (version for which site is protocol registered)
Done
Investigational agent accountability logs
Done
Participant prescriptions
Done
Documentation of study drug transfers, returns, and destruction (if applicable)
Done
Ordering/shipping receipts
Done
Participant-specific profiles (if applicable)
Done
DAIDS-approved, signed Pharmacy Establishment Plan
Done
Required pharmacy operations SOPs as listed in the PAB Pharmacy Guidelines (July 2008)
Done
Laboratory
1
92.86%
Locate, compile, organize, and review documents for accuracy and completeness
CV of Laboratory Director
Done
CVs of key laboratory personnel
Done
Licenses of laboratory personnel (if applicable)
Done
Laboratory certifications
Done
Laboratory normal ranges
Done
Laboratory Data Management System (LDMS) records
Done
Copies of laboratory audits, action plans, and corrective action reports
Done
Specimen logs (present and readily available for review)
Done
Chain of Custody SOP (or similar process document)
Done
Corresponding control data for assays where laboratory result AEs and EAEs were identified
Done
Temperature logs for applicable equipment (refrigerators, freezers, storage cabinets, etc.)
To Do
Notes
Will get a copy.
Calibration and maintenance records for all laboratory equipment (if applicable)
Done
Corrective action reports for identified temperature excursions
Done
Vertical audit of laboratory results and corresponding QC data for results of a randomly selected sample
Done
Completion
General comments and observations
Overall we are almost ready compared to earlier this week. A few more people to meet (Andrew and Marianne) to discuss about the preparation and some tasks to do.
Sign off
Mike Chadwick
16th Nov, 2018 4:57 PM +08