Tag: fda inspector

FDA expectation from you during Design Control portions of Inspections

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Subsystems interacting with The Design Control Process Management Controls Production and Process Controls Corrective and Preventive Action Document and Record Control Labeling and Packaging Control Risk Management Change Control QSIT Design control requirements Your Firm must have a 21 CFR 820.30 compliant design control process prior to submitting a 510(k), as well as during IDE Read more about FDA expectation from you during Design Control portions of Inspections[…]

FDA inspection – Effective SOP for participants duty

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Following are key points need to be followed to have a successful FDA inspection. following people play major role in FDA inspections and hence the roles and responsibilities must be defined well and informed. -Receptionist Maintains a Current Inspection Contact List Actively in Contacting Key Personnel Trained on FDA Inspection SOP Does notReview – FDA Read more about FDA inspection – Effective SOP for participants duty[…]

Records FDA inspectors look for – related to Quality system

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The FDA’s QSR expects the manufacturer to maintain a series of documents that describe the design and production of the device. QSR allocated the information into four documents. The Design History File (DHF) gives a history of device design. One of the design outputs is the Device Master Record (DMR). The Device Master Record (DMR) Read more about Records FDA inspectors look for – related to Quality system[…]