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Pennsylvania Statutes Title 35 P.S. Health and Safety § 2161. Inspection

Current as of January 01, 2025 | Updated by Findlaw Staff

The department shall have the authority to:

(1) Investigate the facts submitted in an application for permit or renewal of a permit by any person to operate a clinical laboratory and conduct inspections as necessary.

(2) Promulgate regulations for the criteria and manner to investigate or inspect a clinical laboratory.

(3) Maintain access to and enter upon the premises of a clinical laboratory to enforce the provisions of this act.

(4) Exempt or limit out-of-State clinical laboratories from the department's inspection process provided the out-of-State clinical laboratory:

(i) is certified or accredited under section 353 of the Public Health Service Act (58 Stat. 682, 42 U.S.C. § 263a) and, to the extent applicable, by the state that has issued a license or permit to operate a clinical laboratory; and

(ii) provides proof to the department that the clinical laboratory applying for a permit or renewal of a permit has met the requirements for exemption of the inspection process under this section.

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Cite this article: FindLaw.com - Pennsylvania Statutes Title 35 P.S. Health and Safety § 2161. Inspection - last updated January 01, 2025 | https://codes.findlaw.com/pa/title-35-ps-health-and-safety/pa-st-sect-35-2161/

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