FDA Observations Audit Management

1. Missing Quality Audits

Root Cause:
Lack of internal audit schedule, inadequate adherence to QMS procedures, understaffing, and oversight of audit activities.

Corrective Action:
Develop a documented internal audit schedule, conduct immediate audits, train additional personnel, and revise SOPs to emphasize internal audits.

Preventive Action:
Regularly train staff on audits, establish a reminder system, implement CAPA for audit findings, and update the audit schedule and procedures regularly.

Reference FDA 483:
Company Name: Theranos, Inc.
Issue Date: 16-Sep-15
Inspection Dates: 25 Aug 2015 to 16 Sep 2015
Investigators: Mary R Hole, Yung W Chan, Lawrence Farina

2. Equipment Design Does Not Facilitate Intended Use

Root Cause:
No internal audit schedule, inadequate quality oversight, and insufficient resources for audits.

Corrective Action:
Develop a comprehensive audit schedule, allocate resources, and mandate training on the importance of audits.

Preventive Action:
Prioritize audits in the QMS, incorporate audits into performance metrics, and regularly update the audit schedule based on changes and findings.

Reference FDA 483:
Company Name: Chen Shwezin, Inc. dba Park Compounding
Issue Date: 11-Sep-15
Inspection Dates: 31 Aug 2015 to 11 Sep 2015
Investigators: Liming Zhang, Darren S Brown, Lawrence Farina

3. Inadequate Specifications for Components

Root Cause:
Lack of robust audit scheduling, oversight, and prioritization within the QMS.

Corrective Action:
Implement audit management software, allocate resources, and prioritize audits with top management oversight.

Preventive Action:
Form a cross-functional audit committee, integrate audit reviews into senior management meetings, and train employees on the importance of audits.

Reference FDA 483:
Company Name: Wood's Pharmacy, Inc., dba The Medicine Shoppe
Issue Date: 15-Jan-15
Inspection Dates: 12 Jan 2015 to 15 Jan 2015
Investigators: Tajah L Blackburn, Nebil A Oume

4. Inadequate Maintenance of Equipment and Utensils

Root Cause:
Lack of CAPA procedures for level 3 investigations, insufficient regulatory understanding, inadequate training, absence of tracking tools, and poor management commitment.

Corrective Action:
Develop CAPA procedures, train personnel, institute a tracking system, and conduct management reviews to reinforce compliance.

Preventive Action:
Regular audits, mandatory management reviews, and continuous training on regulatory requirements and procedures for level 3 investigations.

Reference FDA 483:
Company Name: Downing Labs, LLC
Issue Date: 16-Jul-14
Inspection Dates: 03 Jun 2014 to 16 Jul 2014
Investigators: Stephen D Brown, Darla J Christensen

5. Inadequate Establishment of Quality Audit Procedures

Root Cause:
Lack of detailed audit planning, insufficient audit scope and frequency, and inadequate coverage of quality systems.

Corrective Action:
Revise audit procedures, implement a detailed schedule, and train audit personnel.

Preventive Action:
Regularly review and update audit procedures, audit the audit process for improvement, and enhance training on strategic planning and scope definition.

Reference FDA 483:
Company Name: Hospira, Inc.
Issue Date: 17-Jun-11
Inspection Dates: 16 May 2011 to 17 Jun 2011
Investigators: Jason F Chancey, Penny H McCarver

6. Lack of SOP and Documented Procedures

Root Cause:
No SOPs for vendor qualification, lack of regulatory understanding, inadequate resource allocation, and miscommunication on vendor qualification importance.

Corrective Action:
Develop and implement SOPs for vendor qualification, allocate resources, audit current vendors, update QMS, and consult regulatory experts.

Preventive Action:
Establish continuous training, periodically review SOPs, implement a vendor management system, and promote a culture of quality and compliance.

Reference FDA 483:
Company Name: Time Cap Labs, Inc.
Issue Date: 05-May-98
Inspection Dates: 26 Mar 1998 to 05 May 1998
Investigators: Lawrence Farina, Robert C Horan

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