(a)Prior to issuing a license required by Section 111615 to any place of business where a drug or device is manufactured, the department shall receive from each place of business documentation that evidences ownership and any of the following:
(1)The place of business is operating pursuant to a valid biologics license issued by the
United States Food and Drug Administration in compliance with Section 351 of the federal Public Health Service Act (42 U.S.C. Sec. 262).
(2)The place of business is operating with a valid establishment registration pursuant to Section 510 of the federal act (21 U.S.C. Sec. 360). This documentation shall include an attestation from an officer of the place of business that a federal inspection was completed within the two years prior to the date of the at
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(a)
Prior to issuing a license required by Section 111615 to any place of business where a drug or device is manufactured, the department shall receive from each place of business documentation that evidences ownership and any of the following:
(1)
The place of business is operating pursuant to a valid biologics license issued by the
United States Food and Drug Administration in compliance with Section 351 of the federal Public Health Service Act (42 U.S.C. Sec. 262).
(2)
The place of business is operating with a valid establishment registration pursuant to Section 510 of the federal act (21 U.S.C. Sec. 360). This documentation shall include an attestation from an officer of the place of business that a federal inspection was completed within the two years prior to the date of the attestation.
(3)
The place of business is operating in compliance with audits conducted pursuant to the International Standards Organization (ISO) 9000 series, ISO 13485:2003 quality management systems standards, ISO 15378:2006 quality management systems standards, pursuant to Parts 210 and 211 of Title 21 of the Code of Federal Regulations, or pursuant to Part 820 of Title 21 of the Code of Federal Regulations.
(4)
The place of business is operating pursuant to an approved investigational new drug issued by the federal Food and Drug Administration pursuant to Section 312.20 of Title 21 of the Code of Federal Regulations or pursuant to an approved investigational device exemption issued by the federal Food and Drug Administration pursuant to Section 812.20 of Title 21 of the Code of Federal Regulations.
(b)
If the department receives documentation that satisfies the requirements of subdivision (a), the department shall not inspect the place of business prior to issuing a license required by Section 111615. If the department does not receive the documentation required, the department shall inspect the place of business prior to issuing a license required by Section 111615.
(c)
Upon request by a place of business licensed under
Section 111615, the department shall provide an official copy of the valid license to the place of business in accordance with Sections 110230 and 110235.
(d)
Notwithstanding Section 111640, for any place of business where a drug or device is manufactured and the manufacturer has received a license pursuant to this section, the department shall make investigations or inspections authorized by Article 2 (commencing with Section 110140) of Chapter 2 only when any of the following occur:
(1)
The department becomes aware of an issue and makes a determination that the health and safety of the public is at risk.
(2)
A complaint has been registered with the department and the department makes a determination that the health and safety of the public is at risk.
(3)
A notification has been sent by the United States Food and Drug Administration to the department that requests assistance regarding any Class I or II recall action memorandum.
(4)
The United States Food and Drug Administration has requested assistance for enforcement activities, including, but not limited to, embargoes, seizures, or injunctions.
(e)
Inspections made pursuant to subdivision (d) shall be limited to inspections for compliance with, or violations of, Chapter 4 (commencing with Section 110290) or this chapter.