---
title: Conducting a Mock FDA Audit of Medical Device Manufacturer (Singapore)
description: Read how SeerPharma helped a medical device manufacturer with US FDA 21 CFR Part 820 – Quality System Regulation compliance through a 3-day mock audit.
---

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# [Conducting a Mock FDA Audit of Medical Device Manufacturer (Singapore)](https://blog.seerpharma.com/conducting-a-mock-fda-audit-of-medical-device-manufacturer-singapore)

 Written by [SeerPharma](https://blog.seerpharma.com/author/seerpharma) | Sep 5, 2024 2:01:55 AM

A multinational manufacturer of cardiovascular devices recently engaged SeerPharma to conduct a comprehensive mock US FDA audit of their operations in Singapore. The audit was conducted against US FDA 21 CFR Part 820 – Quality System Regulation (21 CFR 820). SeerPharma reviewed relevant documentation remotely and then spent three days on-site reviewing manufacturing operations and activities.

SeerPharma assessed the following areas of the company’s operations over three days.

| **Process** | **21 CFR 820 Reference** |
| --- | --- |
| **Quality System ** - Control of records related to the QMS - Quality Manual - Quality Policy, Quality Objectives - Training Program |   Sec. 820.5 Quality System Sec. 820.20 Management Responsibility |
| **Management Responsibility** - Review of the process in place, planned schedule of meetings, minutes of previous meetings, and follow-up actions - Adequacy of management commitment to quality and compliance - Implementation and effectiveness of the quality policy - Establishment and communication of quality objectives |   Sec. 820.20 Management Responsibility |
| **Document Controls** - Compliance with requirements for the creation, approval, distribution, and maintenance of documents - Procedures for document change control and document retrieval |   Sec. 820.40 Document Controls |
| ****Corrective and Preventive Action **** - Documentation and investigation of nonconformities and customer complaints - Implementation and effectiveness of corrective and preventive actions to address root causes of issues - Control of nonconforming product - Nonconformity review and disposition |   Sec 820.90 Nonconforming Product Sec 820.100 Corrective and Preventive Action Sec 820.198 Complaint Files |
| ****Design Controls **** - Documentation of design transfer, inputs, outputs, reviews, verification, validation, and design changes - Procedures for control of design and development activities  |   Sec. 820.30 Design Controls (h) Design transfer (i) Design changes Sec 820.181 Device Master Record |
| ****Purchasing Controls **** - Verification that purchased components, materials, and services meet specified requirements - Establishment and maintenance of procedures for supplier evaluation, selection, and monitoring - Control of processes for supplier evaluation and approval - Purchasing controls and processes - Receipt and release of materials and product |   Sec 820.50 Purchasing Controls (a) Evaluation of suppliers, contractors, and consultants (b) Purchasing data |
| Production and Process Controls - Adherence to procedures for production and process control, including cleanliness, maintenance, and calibration of equipment - Implementation of process validation activities as required - Management of product labelling, packaging, and shipping processes - Material Control - Identification and Traceability - Batch review and release - QC testing - Automated processes - Personnel - Manufacturing materials - Management of Equipment and Facilities Calibration, maintenance procedures - Environmental Controls - Contamination Control |   Sec 820.70 Production and Process Controls Sec 820.50 Purchasing Controls  |
| Measurement and Analysis - Internal Audit - Implementation of internal quality audits to ensure compliance with regulatory requirements - Documentation and follow-up on audit findings and corrective actions |   Sec 820.22 Quality Audit |
| **Records** - Maintenance and retention of records related to the QMS, including production, quality control, and distribution records |   Sec 820.180 General Requirements Sec 820.184 Device History Record  |

Following the mock FDA audit, SeerPharma presented a comprehensive report to the client classifying findings as follows:

#### Critical

- A system that has deficiencies that indicate a significant risk that a product could or would be harmful to the user.
- Evidence that the Management Team is/are not exercising their responsibilities.

#### Major

- A system that has deficiencies that indicate a potential risk to product or data integrity.
- A finding that is a departure from the standard or procedural requirements, or for which there is no evidence of compliance.
- A finding that has a high probability of leading to a Major Finding during a regulatory FDA inspection.

#### Minor or Other

- A system that has deficiencies that may indirectly produce an invalid test result or is a deviation from approved procedure or good manufacturing practices.
- A finding that, depending on the circumstances, may lead to a Major Finding during a regulatory FDA inspection.
- A system that has deficiencies which cannot be classified as a Major, but which indicates a minor departure from approved procedures.

#### Recommendation

- Feedback or recommendations regarding opportunities for improvement to the quality management system or individual procedures. 

The mock inspection and observations by SeerPharma are intended to assist the client in preparing for an impending US FDA inspection.

SeerPharma has over 35 years of industry experience conducting mock GMP regulatory inspections by health authorities such as the US FDA, MHRA, TGA, HSA and other PIC/S member authorities. Our team of seasoned experts can provide a comprehensive independent review of your operations, to help you prepare for regulatory GMP inspections.

Visit [https://www.seerpharma.com/services/qa-and-gmp-consulting/auditing](https://www.seerpharma.com/services/qa-and-gmp-consulting/auditing) to learn more about SeerPharma’s auditing services and [contact us](https://www.seerpharma.com/contact-us) if you’d like support with mock GMP regulatory inspections.

[View full post](https://blog.seerpharma.com/conducting-a-mock-fda-audit-of-medical-device-manufacturer-singapore)

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