Short FDA inspection preparation guides
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Short, focused preparation briefs with source context, records to retrieve, questions to discuss, and a practical exercise. Browse descriptions publicly; create a free account to read the complete briefs.
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In vitro diagnostics · Testing & laboratory work
IVD hematology: define the instrument and reagent configuration
Review the configuration used for a specific evaluation, its reagent and control identities, maintenance status, and retained evidence. Keep a demonstration separate from a clinical performance claim.
Sign in to read →In vitro diagnostics · Testing & laboratory work
IVD immunoassays: connect calibrators and controls to the reported decision
Map the relationship among calibrator identity, control results, reagent lot, instrument status, and the reportable use. Do not infer clinical acceptance limits from this brief.
Sign in to read →In vitro diagnostics · Testing & laboratory work
IVD molecular testing: trace reagent, run, and result interpretation
Follow a training run through specimen or control identity, reagent lot, instrument configuration, acceptance decisions, and interpretation. Use the product’s intended use and instructions; this is not a clinical testing protocol.
Sign in to read →Contract laboratories · Testing & laboratory work
Contract laboratory report amendments: preserve the original conclusion
Follow the reason for amendment, supporting original data, review, distribution, and traceability to the prior report. A replacement PDF alone does not explain what changed.
Sign in to read →Contract laboratories · Testing & laboratory work
Contract laboratory subcontracting: follow the second handoff
Identify work sent to another laboratory, authorization, method expectations, data access, and report attribution. Do not imply that accreditation alone establishes suitability for every test.
Sign in to read →Contract laboratories · Testing & laboratory work
Contract laboratory sample receipt: preserve the chain of evidence
Trace a sample from the client’s instructions to receipt, condition assessment, identification, storage, aliquoting, and test assignment. Product testing and clinical testing can fall under different frameworks.
Sign in to read →Contract laboratories · Quality & documentation
Contract laboratory quality agreements: clarify the decision owner
Map responsibilities for methods, samples, deviations, original data, subcontracting, reports, and communication. An agreement describes allocation; verify which legal responsibilities remain with each party.
Sign in to read →Contract laboratories · Quality & documentation
Good documentation practice: explain a correction without obscuring the original
Review how a correction is attributed, explained, reviewed, and retained under the applicable procedure. Keep the original observation retrievable; never reconstruct missing data by guessing.
Sign in to read →Pharmaceuticals · Facilities & utilities
Facility maintenance: close the work order and the quality question
Trace maintenance from authorization through work performed, cleanup, checks, and return to use. Completion of a work order does not by itself describe the evidence supporting a product-impact decision.
Sign in to read →Food · Facilities & utilities
Pest control: follow a finding into a documented response
Examine the location, trend, material exposure, contractor report, and follow-up. Keep the factual observation distinct from assumptions about contamination or affected-product scope.
Sign in to read →Pharmaceuticals · Facilities & utilities
HVAC: connect room use to the control strategy
Compare room purpose, airflow design, monitoring, maintenance, and changes. Avoid borrowing universal pressure, air-change, or particle limits without a justified applicable basis.
Sign in to read →Medical devices · Assembly & fabrication
Ceramic components: trace a critical characteristic through fabrication
Follow one ceramic component from incoming material through fabrication and acceptance. Connect the characteristic being assessed with the device’s intended use instead of assuming every ceramic process is regulated alike.
Sign in to read →Medical devices · Assembly & fabrication
Polymerization: connect a material change to the finished device
Focus on material identity, approved process boundaries, batch history, and the assessment of a change. This preparation brief does not prescribe a chemical recipe or operating conditions.
Sign in to read →Biologics, blood & cells · Incoming materials
Cell processing: preserve identity through a handoff
Trace a training example through receipt, identification, processing, storage, and transfer. Use the actual product’s regulatory framework; not every cell-related activity has the same requirements.
Sign in to read →Biologics, blood & cells · Incoming materials
Plasma processing: define whether the term means a material or a treatment
Start by distinguishing blood plasma processing from plasma-based surface treatment or sterilization. The word alone does not identify the product, hazards, or applicable regulatory framework.
Sign in to read →Medical devices · Packaging & labeling
Packaging change control: connect the new material to the product
Review the reason for a packaging change, supplier information, product protection, distribution conditions, and any assessed effects on sterilization or labeling.
Sign in to read →In vitro diagnostics · Packaging & labeling
Label reconciliation: explain a count discrepancy
Trace issued, used, returned, and rejected labels against the site’s approved reconciliation method. Do not invent an acceptable discrepancy or treat a count as proof that every label was correct.
Sign in to read →Medical devices · Assembly & fabrication
PCB assembly: follow a reworked board back to its configuration
Use a reworked board to examine component identity, approved configuration, rework instructions, test coverage, and disposition. Applicability depends on the device and the role of the board.
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Industry learning clusters
- Contract laboratory learning cluster
- Laboratory learning cluster
- Pharmaceutical learning cluster
- Medical device learning cluster
- IVD learning cluster
- Biologics, blood and cell learning cluster
- Cosmetics learning cluster
- Dietary supplement learning cluster
- Food learning cluster
- Animal health learning cluster
- Clinical research learning cluster