Food · Quality Control · Intermediate
Conduct quarterly or semi-annually. Walk all production areas, warehousing, and grounds. Observe practices during active production. Document evidence for each finding.
An internal audit form for quality managers assessing facility compliance with FDA current Good Manufacturing Practice requirements under 21 CFR Part 117 Subpart B. Covers personnel practices, building and grounds condition, equipment sanitary design, production and process controls, and warehousing and distribution — the foundational requirements that underpin the entire food safety system.
cGMP violations are among the most frequently cited observations on FDA Form 483s. This checklist identifies the specific areas FDA investigators examine during routine inspections, helping facilities find and correct deficiencies before they become official observations or warning letter findings.
This checklist template is provided as a general-purpose resource and is not tailored to the regulatory requirements of any specific country, region, or jurisdiction. It is the responsibility of each organisation to review and adapt this template to ensure compliance with all applicable local laws and regulations. Miratag does not accept liability for any inaccuracies or omissions, or for any actions taken based on this template.
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