The COFEPRIS sanitary verification visit is the instrument the Mexican health authority uses to inspect pharmaceutical facilities, warehouses, pharmacies and laboratories on site: a verifier shows up unannounced, presents a written order and documents everything observed in an official record. For anyone manufacturing, importing or distributing medicines in Mexico — or exporting to the Mexican market — knowing exactly how the visit unfolds, what rights the inspected party has and which documents must be ready makes the difference between a routine verification closed without findings and an administrative proceeding with safety measures and penalties. This guide walks through the process step by step, with verified regulatory references and a practical readiness checklist.
What the COFEPRIS sanitary verification visit is and who conducts it
COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) is the body of Mexico's Secretaría de Salud responsible for protection against sanitary risks: it authorizes, oversees and sanctions establishments handling health products — medicines, APIs, medical devices and other regulated goods. The verification visit is the surveillance act provided for by the Ley General de Salud (LGS): an on-site inspection by accredited verifiers to confirm that the establishment complies with applicable health legislation — licenses and operating notices, the responsable sanitario, hygienic conditions and, for manufacturers, the good manufacturing practices (GMP) of NOM-059-SSA1-2015.
Visits are either ordinary, scheduled under surveillance programs, or extraordinary, triggered for instance by complaints, health alerts, pharmacovigilance signals or sampling results. The procedural framework is the same in both cases, and the inspected party keeps the same rights.
The legal basis: Ley General de Salud and LFPA
The legal foundation of the verification is Title Seventeen of the Ley General de Salud ("Vigilancia Sanitaria"), in particular articles 396-404: article 396 frames sanitary surveillance, article 398 distinguishes ordinary and extraordinary visits, articles 399-401 govern the conduct of the visit and the rights of the inspected party, and article 404 lists the safety measures the authority may impose when it identifies a health risk. In parallel, the Ley Federal de Procedimiento Administrativo (LFPA) applies: its article 68 grants the inspected party the right to state observations in the record itself and to submit evidence within five days of the closing of the acta.
For manufacturing sites, the technical reference of the verification is NOM-059-SSA1-2015 on good manufacturing practices for medicines (updated by the emergency modification published in the Diario Oficial de la Federación on 23 August 2023): it is the standard against which the verifier assesses the quality system, documentation, premises, validations and deviation management.
How the visit unfolds: from the verification order to the acta
The visit follows a precise formal sequence. Any skipped or irregular step can be challenged by the inspected party, which is why it pays to know it by heart:
| Phase | What happens | What the inspected party should check |
|---|---|---|
| 1. Identification | The verifier presents the official credential | Photograph, signature, number, issue date and validity of the document |
| 2. Verification order | Delivery of the authority's written order | Date, establishment to be verified, scope and legal grounds, names of the verifiers, signature of the competent authority |
| 3. Witnesses | The inspected party designates two witnesses | If the inspected party declines, the verifier designates them: better to choose them among your own staff |
| 4. Walkthrough | Inspection of areas, documents and sanitary conditions; possible sampling | Always accompany the verifier; keep internal notes of what is examined |
| 5. Acta de verificación | Drafting of the detailed record with the anomalies found | Read it in full, have your observations recorded, receive a copy |
The acta de verificación is the document that carries weight throughout the subsequent proceeding: what is not put on record during the visit will be much harder to assert later.
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The rights of the inspected party and the five-day window
During and after the visit, the inspected party is not a passive subject. The main rights, recognized by the LGS and the LFPA, are:
- checking the verifier's identity and the regularity of the verification order before granting access;
- designating the two witnesses who attend the visit;
- having everything relevant to your defense recorded in the acta itself;
- receiving a copy of the acta at the end of the visit;
- submitting observations and documentary evidence within five days of the closing of the record (art. 68 LFPA).
That five-day window is often the wasted opportunity: many companies let it pass without filing the evidence that would have scaled down the findings. It is worth defining in advance in an SOP: who gathers the evidence, who drafts the submission, who files it and how delivery is documented.
What happens after the visit
Once the acta is closed, the authority evaluates what was observed together with the observations and evidence submitted by the inspected party. Possible outcomes range from closure without findings to required corrections and — where a health risk emerges — the safety measures of article 404 LGS, such as product seizure or partial or total suspension of activities, plus the administrative penalties provided by the same law. Safety measures are immediate and precautionary: they do not replace the sanctioning procedure, they precede it. This is another reason why the quality of the observations put on record and of the evidence filed within the five days directly affects the final outcome.
How to prepare: documentation ready and GMP under control
Effective preparation does not start when the verifier rings the bell. The points a pharmaceutical establishment must keep permanently audit-ready are:
- Authorizations and notices: licencia sanitaria or aviso de funcionamiento up to date and matching the activities actually performed, a valid responsable sanitario notice.
- Quality documentation: current signed SOPs, production and control records, deviation management, CAPA and change control aligned with NOM-059-SSA1-2015.
- Premises and operating conditions: areas consistent with what is authorized, documented temperature-controlled storage, expired or quarantined products segregated and identified.
- Personnel: documented training, an up-to-date organization chart, clear delegation of who receives and accompanies the verifier on every shift.
- Internal drills: periodic self-inspections run with the same format as the COFEPRIS acta, so that no question comes up for the first time during the real visit.
GuideGxP recommendation
Treat the COFEPRIS visit as you would an EMA or FDA inspection: a dedicated inspection-management procedure, a defined front room/back room, an always-current site master file and the five-day window owned by a named role. If you operate from Europe toward Mexico, map the differences between EudraLex and NOM-059-SSA1-2015 instead of assuming equivalence: the verifier measures against the Mexican standard, not yours. And after every visit — real or simulated — close the loop with effectiveness-checked CAPAs.
Browse our catalog of ready-to-use GxP manuals and templates: operational guides and Excel/Word toolkits to reach every inspection with the documentation already in place.
