Independent facility and internal GMP audits led personally by Roberto L. Rivera — 45 years of cGMP experience, former Pfizer Senior Audit Manager. An outside auditor's eyes on your own operation, mapped to the regulations that actually govern your products.
Your internal auditors are capable people. They are also auditing systems they helped design, procedures they wrote, and colleagues they will see at lunch. That is not a criticism of anyone's integrity — it is simply how familiarity works. The deviation everyone has walked past for two years stops registering as a deviation.
An FDA investigator arrives with none of that history. They see the facility cold, ask the obvious question nobody inside has asked lately, and follow the thread wherever it goes. The value of an outside auditor is that they arrive the same way — except the findings come to you first, with time to act.
There is a capacity dimension too. Annual internal audit schedules slip when the team is stretched across production support, deviations, and supplier work. Independent audit capacity keeps the schedule intact instead of perpetually behind.
"I'm terrified we'll fail our next inspection because my team is too stretched to see our own blind spots. I need someone who has been in the trenches to tell me what's actually broken."
That is the core of every facility audit engagement. Roberto assesses your site the way an investigator would — and delivers a prioritized findings report your team can act on before anyone from an agency arrives.
Scoped to your operation and the regulations that govern it. Roberto is your Lead Auditor throughout.
Comprehensive assessment of manufacturing operations, facilities, utilities, and equipment against FDA 21 CFR 210/211, 820, EMA, Health Canada, and regional standards.
Review of change control, deviations, investigations, batch record review, training, document control, and management review — the systems an investigator examines first.
Assessment of your own audit program: scope, scheduling, auditor competence, findings rigor, and closure discipline — plus program and checklist development where gaps exist.
Evaluation of whether closed CAPAs actually resolved root cause and held — the recurring finding that turns a routine inspection into an escalating one.
ALCOA+ assessment across laboratory and manufacturing systems, including audit trails, access controls, and record review practices.
A written report ranked by regulatory risk, an executive summary for leadership and the Board, and 90 days of remote advisory support after delivery.
Roberto responds within one business day, reviews your operation, product types, regulatory history, and objectives, then builds the audit plan and agenda. A mutual NDA can be executed first.
Systems, facilities, documentation, and the production floor — with real-time observations and a daily debrief so leadership knows what is emerging before the report lands.
A written report with every finding mapped to the specific regulation and ranked by regulatory risk, so effort goes where the exposure actually is.
A concise summary written for the CEO and Board — what the risk is, what it will take to close, and what happens if it is not closed.
Remote support through the first ninety days of implementation, so questions that surface during execution get answered by the person who wrote the findings.
You work directly with Roberto L. Rivera — not a rotating team of junior associates. A former Pfizer Senior Audit Manager with 45 years across the world's most regulated facilities, Lead Auditor for Initial, Routine, Directed, Pre-Approval, and Facility audits across five global regulatory regions. Facility audits are backed by the Zero Warning Letter Guarantee, subject to the terms of the engagement letter.
Internal teams audit systems they helped build and work in every day, which makes genuine objectivity difficult regardless of skill or intent. An independent auditor sees the site the way an investigator would, has no history with the deviations under review, and can raise findings without organizational consequence.
Independent audits performed on your behalf can be incorporated into your internal audit program and self-inspection schedule, documented to your procedures. Many clients use an outside auditor for part of their annual schedule to add objectivity and to cover sites their internal team cannot reach.
FDA 21 CFR Parts 210 and 211, 21 CFR Part 820 for devices, ICH Q7, Q9, and Q10, EU GMP including Annex 1, Health Canada, and applicable regional Board of Health standards — scoped to the regulations that actually govern your products and markets.
Most facility GMP audits run one to two weeks on site depending on the size and complexity of the operation, at $11,250 per week. The engagement includes a prioritized findings report, an executive summary, and 90 days of remote advisory support afterward.