Cannabis Laboratories

Compliance Inspections

The Office may perform compliance inspections and laboratory regulatory audits. By signing and submitting a permit application, licensees provide voluntary consent for the Office to conduct inspections, site visits, or investigations (NYCRR §133.3(a)) at any time during the licensing cycle or before a final license is issued.
 

NYCRR §130.1(j) defines a laboratory regulatory audit as an on-site or virtual assessment or audit conducted by the Office, or by a state regulatory program recognized by the Office pursuant to this Part. The audit will be performed every two years during the laboratory’s normal business hours.

Refusing entry or failing to cooperate during an inspection may result in a  Stop Work Order or Summary Suspension Order (NYCRR §133.6(a)(5)–(6)). 

Inspections may include: 

• On-site visits to licensed locations (inspectors must be granted access to all areas — NYCRR §133.3(e))

• Desk audits

• Interviews with employees, contractors, managers, supervisors, or others involved in financing, management, or operations

• Requests or subpoenas for records, books, payrolls, accounts, electronic communications, and other business materials

Inspections may be announced or unannounced, and the inspection may target all areas of testing or an analyte or group of analytes. 

Inspectors use the following checklists, when applicable:

Inspectors may review a wide range of requirements, including:

• competence and qualifications of staff,

• adequacy of facilities and equipment,

• appropriateness of sampling protocols,

• use of approved methods,

• quality assurance and quality control procedures,

• record keeping, and 

• reporting practices. 

If one or more deficiencies are found during an inspection, the Office will issue a Statement of Findings (SOF) or Audit Report. The licensee must then provide a written Corrective Action Plan (CAP) or Report (CAR) in response to the SOF or Audit Report.  

Additional details related to SOF and CAP are described here:

 What Happens After an Inspection

If the licensee receives an audit report, the licensee may be granted a grace period not to exceed ninety (90) calendar days from the date of the audit report to correct the findings. The licensee must submit a written corrective action plan within thirty (30) calendar days from the audit report for approval by the Office.