Alabama Administrative Code › Title 538 - ALABAMA MEDICAL CANNABIS COMMISSION › Chapter 538-X-4 - Licensee Requirements - Generally › Section 538-X-4-.02 - Post-Licensing Inspection Of Facilities

Current through Register Vol. 42, No. 9, June 28, 2024
(1)
Generally.
Inspections
			 of licensees (except cultivators, who shall be inspected under procedures set
			 forth in Rule 80-14-1-.10, promulgated by the Department) shall be carried out
			 by the Commission in accordance with §
								20-2A-52(a)(3),
Code of Ala. 1975
, (as amended). Immediately prior to
			 commencing operations and, thereafter, no less often than annually (and more
			 often, depending on the type of license provided), a licensee shall undergo at
			 least one announced inspection by the Commission or its representatives; the
			 licensee may also be subject to one or more unannounced inspections.
(2) Announced Inspections.
(a) Pre-Commencement Inspection. When a
			 licensee is set to commence operations at any facility, the licensee shall
			 contact the Commission to set a date for inspection under the procedures for an
			 announced inspection set forth in this Chapter, except that the
			 Pre-Commencement Inspection may be set at any mutually acceptable time. No
			 licensee's operations may commence at any facility until the facility has
			 passed a pre-commencement inspection with no critical violations and all minor
			 infractions having been corrected. Reinspection following a failed
			 pre-commencement inspection shall occur within 30 days, after which, if the
			 licensee passes the inspection it may commence operations; a licensee having
			 failed a second pre-commencement inspection must petition the Commission for
			 permission for a further pre-commencement inspection; if the Commission denies
			 a third pre-commencement inspection or the licensee fails the third inspection,
			 the licensee is precluded from commencing operations and its license shall be
			 revoked.
(b) Announced Inspections
			 Generally.
1. Timing. Not less than 14 days
			 prior to any announced inspection, the Commission, acting by and through its
			 representative, will notify the licensee of its intention to conduct an
			 announced inspection of the licensee's facilities, operations, and
			 documentation, advising the licensee of a specific date and time for the
			 inspector's anticipated arrival as well as the individuals who are anticipated
			 to be part of the inspection team.
2. Scope. At the time of the announced
			 inspection, licensees shall make their facilities, personnel, operations, and
			 documentation available for review and auditing at the request of the
			 inspector. Areas of inspection shall include, but are not limited to: all areas
			 of all facilities that have been in operation at any time since the last
			 announced inspection; all facilities not in operation that the licensee is
			 planning to put in operation at any time during the next two years; proper
			 credentialling, licensing, qualifications, education, suitability and
			 experience, as applicable, for all personnel, including owners, officers,
			 administrators, managers, employees (full-time or part-time) and volunteers;
			 all operations and processes being conducted by the licensee, including but not
			 limited to, all machinery, equipment and supplies; all security monitoring and
			 video surveillance files and log book data maintained by the licensee; all IT
			 files maintained by the licensee, including but not limited to the licensee's
			 test results, any third-party inventory control and tracking systems, and the
			 Statewide Seed-to-Sale Tracking System; background check certificates and/or
			 personnel files of all owners, officers, administrators, managers, employees
			 (full-time or part-time), and volunteers; and all documents provided to the
			 Commission at the time of licensing, including all updates to such documents
			 made at any time since the last announced inspection, with or without the
			 permission of the Commission. (See 538-X-4-.07 of this Chapter.)
3. Compliance liaison. Throughout the
			 announced inspection, the licensee shall have a designated compliance liaison
			 who is knowledgeable about the licensee's facilities, personnel, operations,
			 and documentation, and who will be on hand to answer questions or coordinate
			 with additional persons to provide answers or information in response to
			 questions by the inspection team.
4. Duty of Cooperation. The licensee is
			 expected to comply with all inspections with the highest level of integrity and
			 transparency. Failure to cooperate with an inspection by the Commission may
			 lead to sanctions, within the Commission's discretion, up to and including
			 revocation of license.
(c) Unannounced Inspections.
1. Timing. Unannounced Inspections may be
			 conducted without prior notice at any time, without respect to whether the
			 licensee has or has not undergone an announced inspection.
2. Scope. An unannounced inspection may cover
			 any and all areas described above with respect to announced
			 inspections.
3. Procedures. The
			 licensee shall, at the time of licensing, receive confidential instructions
			 relating to procedures that will be implemented immediately before the
			 unannounced inspection begins. The licensee shall follow these instructions and
			 can therefore be secure in the knowledge that the inspection is authentic and
			 is being carried out at the instance of the Commission and not
			 otherwise.
4. Point of Contact. At
			 the time of any unannounced inspection, the licensee shall identify to the
			 inspectors an acceptable point-of-contact for the inspection, usually one of
			 the leaders of the company then on duty, who will fill the role of compliance
			 liaison (as set forth in subparagraph 2.b.(3) of this rule) in all respects
			 possible for the unannounced inspection.
5. Duty of Cooperation. To the extent the
			 Commission follows the confidential procedures set forth at the time of
			 licensing, the licensee, during an unannounced inspection, has the same
			 obligations of cooperation as with an announced inspection, and the same
			 consequences for failing to cooperate.