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§ 106-140. Further powers of Commissioner of Agriculture for enforcement of Article; report by inspector to owner of establishment.

§ 106‑140.  Furtherpowers of Commissioner of Agriculture for enforcement of Article; report byinspector to owner of establishment.

(a)        For purposes of enforcement of this Article, theCommissioner or any of his authorized agents, are authorized upon presentingappropriate credentials and a written notice to the owner, operator or agent incharge,

(1)        To enter at reasonable times any factory, warehouse orestablishment in which food, drugs, devices or cosmetics are manufactured,processed, or packed or held for introduction into commerce or after suchintroduction or to enter any vehicle being used to transport or hold such food,drugs, devices or cosmetics in commerce; and

(2)        To inspect at reasonable times and in a reasonable mannersuch factory, warehouse, establishment or vehicle and all pertinent equipment,finished or unfinished materials, containers and labeling therein, and toobtain samples necessary to the endorsement of this Article. In the case of anyfactory, warehouse, establishment, or consulting laboratory in which any food,drug, device or cosmetic is manufactured, processed, analyzed, packed or held,the inspection shall extend to all things therein (including records, files,papers, processes, controls and facilities) bearing on whether any food, drug,device or cosmetic which is adulterated or misbranded within the meaning ofthis Article or which may not be manufactured, introduced into commerce or soldor offered for sale by reason of any provision of this Article, has been or isbeing manufactured, processed, packed, transported or held in any such place orotherwise bearing on violation of this Article. No inspection authorized by thepreceding sentence shall extend to

a.         Financial data,

b.         Sales data other than shipment data,

c.         Personnel data (other than data as to qualifications oftechnical and professional personnel performing functions subject to thisArticle),

d.         Pricing data, and

e.         Research data (other than data relating to new drugs andantibiotic drugs, subject to reporting and inspection under lawful regulationsissued pursuant to section 505(i) or (j) or section 507 (d) or (g) of thefederal act, and data, relating to other drugs, which in the case of a new drugwould be subject to reporting or inspection under lawful regulations issuedpursuant to section 505(j) of the federal act).

            Such inspection shall be commenced and completed withreasonable promptness. The provisions of the second sentence of this subsectionshall not apply to such classes of persons as the Board may by regulationexempt from the application of this section upon a finding that inspection asapplied to such classes of persons in accordance with this section is notnecessary for the protection of the public health.

(3)        To have access to and to copy all records of carriers in commerce showing the movement in commerce of any food, drug, device, orcosmetic, or the holding thereof during or after such movement, and thequantity, shipper and consignee thereof: Provided, that evidence obtained underthis subsection shall not be used in a criminal prosecution of the person fromwhom obtained; and provided further, that carriers shall not be subject to theother provisions of this Article by reason of their receipt, carriage, holding,or delivery of food, drugs, devices or cosmetics in the usual course ofbusiness as carriers.

(b)        Upon completion of any such inspection of a factory,warehouse, consulting laboratory or other establishment and prior to leavingthe premises, the authorized agent making the inspection shall give to theowner, operator, or agent‑in‑charge a report in writing settingforth any conditions or practices observed by him which in his judgmentindicate that any food, drug, device or cosmetic in such establishment:

(1)        Consists in whole or in part of any filthy, putrid, ordecomposed substance; or

(2)        Has been prepared, packed or held under insanitaryconditions whereby it may have become contaminated with filth or whereby it mayhave been rendered injurious to health.

(c)        If the authorized agent making any such inspection of afactory, warehouse or other establishment has obtained any salable productsamples in the course of the inspection, upon completion of the inspection andprior to leaving the premises he shall offer reasonable payment for any suchproduct samples.

(d)        It shall be the duty of the Commissioner of Agriculture tomake or cause to be made examination of samples secured under the provisions ofthis section to determine whether or not any provision of this Article is beingviolated. (1939, c. 320, s.21; 1975, c. 614, s. 38.)

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