Follow Us:

US FDA

Home FDA 21 CFR Part 820

Request a Call Back

Interested to know more about FDA QSR 21 CFR Part 820 Implementation or FDA 483 response support, please contact us.

Quick Contact

    FDA 21 CFR Part 820 (Quality System Regulation)

    21 CFR Part 820, Quality System Regulation (QSR) is also known as current Good Manufacturing Practice (cGMP). 21 CFR 820 is for those into the business of manufacturing, contract manufacturing, re-labelling, re-processing or distributing medical devices. 

    The organization must establish and follow quality systems to ensure that their products consistently meet applicable requirements and specifications.

    We are consultants, subject experts and lead auditors support worldwide customers by

    • GMP Implementation support
    • GMP Training
    • Gap analysis audit
    • Full or partial internal QSR audit
    • Supplier audit
    • FDA pre-inspection audit
    • FDA QSR mock audit
    • FDA Post Inspection Support for Closing 483’S

    FDA 21 CFR Part 820

    Applicability of FDA 21 CFR Part 820 Regulation

    The 21 CFR 820  regulation and strict GMP norms applicable for those detailed below.

    • Note 1: Any device that is suitable for human use. No matter the condition of packaging, labelling and nature of sterility.
    • Note 2: Any accessory suitable for human use such as blood tubing and diagnostic x-ray components.

    Fees

    • Remote documentation of Quality Manual & Mandatory Procedure and relevant templates: 1500 USD in 14 working days
    • Onsite Implementation by Interacting process owners by travelling to client location: 600 USD /person-day + travel & Accommodation

    • Understanding of FDA observation and preparing an action plan: 400 USD per each observation  (Remote or Onsite)
    • FDA Response preparation: 600 USD
    • Support in Closing Observation / 483’s : 1500 USD /man-day + travel & Accommodation

    I3CGLOBAL is the best choice for clients in the Asia Pacific, Middle East, and Europe. We have the knowledge and experience to support Medical Device organizations against FDA warning letters 483 responses. Additional benefits are  the following:

     

    1. Will lay Strong foundation for those implementing for the first time
    2. Drafting of important documents
    3. Process owner interaction and explanation of all processes
    4. Awareness and IQA training
    5. Internal Audit support
    6. FDA pre-inspection GAP analysis.

    Subpart A – General Provisions
    § 820.1 – Scope.
    § 820.3 – Definitions.
    § 820.5 – Quality system.

     

    Subpart B – Quality System Requirements
    § 820.20 – Management responsibility.
    § 820.22 – Quality audit.
    § 820.25 – Personnel.

     

    Subpart C – Design Controls
    § 820.30 – Design controls.

     

    Subpart D – Document Controls
    § 820.40 – Document controls.

     

    Subpart E – Purchasing Controls
    § 820.50 – Purchasing controls.

     

    Subpart F – Identification and Traceability
    § 820.60 – Identification.
    § 820.65 – Traceability.

     

    Subpart G – Production and Process Controls
    § 820.70 – Production and process controls.
    § 820.72 – Inspection, measuring, and test equipment.
    § 820.75 – Process validation.

     

    Subpart H – Acceptance Activities
    § 820.80 – Receiving, in-process, and finished device acceptance.
    § 820.86 – Acceptance status.

     

    Subpart I – Nonconforming Product
    § 820.90 – Nonconforming product.

     

    Subpart J – Corrective and Preventive Action
    § 820.100 – Corrective and preventive action.

     

    Subpart K – Labeling and Packaging Control
    § 820.120 – Device labeling.
    § 820.130 – Device packaging.

     

    Subpart L – Handling, Storage, Distribution, and Installation
    § 820.140 – Handling.
    § 820.150 – Storage.
    § 820.160 – Distribution.
    § 820.170 – Installation.

     

    Subpart M – Records
    § 820.180 – General requirements.
    § 820.181 – Device master record.
    § 820.184 – Device history record.
    § 820.186 – Quality system record.
    § 820.198 – Complaint files.

     

    Subpart N – Servicing
    § 820.200 – Servicing.

     

    Subpart O – Statistical Techniques
    § 820.250 – Statistical techniques.