Buying a contract laboratory: quality questions beyond the equipment list
Review sample traceability, methods, original data, client agreements, subcontracting, and reporting when assessing a contract laboratory acquisition.
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Category: Uncategorized
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New regulated facility startup: separate construction from operational readiness
Use practical readiness decisions for equipment, utilities, laboratory work, procedures, training, and release before starting regulated operations.
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FDA facility acquisition data room: records that answer better questions
Organize a regulatory and quality data room around product scope, original evidence, unresolved issues, and ownership of decisions.
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Buying an FDA-regulated facility: how to assess compliance risk
Use a scoped regulatory and quality review when buying a facility or business. Distinguish registration, inspection history, and current operating…
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Building a new GMP facility: where compliance planning starts
Plan a new regulated facility around product scope, material flow, utilities, quality decisions, and evidence before equipment procurement.
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September 2026 FDA Roundup: 483s, Letters and Recalls
A combined September review links selected Form 483s, Warning Letters, and recall notices while keeping dates, source types, and coverage…
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September 2026 FDA Recall Review: Selected Public Notices
September FDA-posted food recall notices illustrate microbial, allergen, lead, and foreign-material concerns. Read exact products, dates, and source limits.
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September 2026 FDA Warning Letter Review
Selected September-dated FDA Warning Letters address aseptic controls, laboratory investigations, quality oversight, and biological-product requirements.
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September 2026 FDA Form 483 Review: Selected Findings
Selected September-issued FDA 483s: airflow studies, laboratory controls, and quality oversight, with issue dates separated from public-release dates.
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IVD QMSR Inspections: Are Internal Audit and Management Review Records Accessible?
FDA’s QMSR FAQs state that management review, quality audit, and supplier audit reports are inspectable. The former Part 820.180(c) exceptions…
