A. The Board or its agents are authorized upon presenting appropriatecredentials and a written notice as to the purpose of the inspection to theowner, operator or agent in charge to enter at reasonable times any factory,warehouse or establishment in which drugs, devices or cosmetics aremanufactured, processed, packed or held for introduction into commerce or toenter any vehicle being used to transport or hold such drugs, devices orcosmetics.
The Board or its agents are authorized to inspect such factory, warehouse,establishment or vehicle and all pertinent equipment, materials, containersand labeling.
In the case of any factory, warehouse, establishment or consulting laboratoryin which prescription drugs are manufactured, processed, packed or held, theinspection shall extend to all things, including records, files, papers,processes, controls and facilities, bearing on compliance with Chapter 34 (§54.1-3400 et seq.) of this title.
No inspection authorized for prescription drugs shall extend to financialdata, sales data other than shipment data, pricing data, personnel data,other than data as to qualifications of technical and professional personnelperforming functions subject to this chapter, and research data.
Each inspection shall be commenced and completed with reasonable promptness.The Board or its agents shall have access to copy all records of carriers incommerce showing the movement in commerce of any drug, device, or cosmeticand the quantity, shipper and consignee. The evidence obtained under thissection shall not be used in a criminal prosecution of the person from whomobtained; and carriers shall not be subject to the provisions of Chapter 34by reason of their receipt, carriage, holding, or delivery of food, drugs,devices, or cosmetics in the usual course of business.
B. If the authorized agent inspecting a factory, warehouse or otherestablishment has obtained any sample in the course of the inspection, uponcompletion of the inspection and prior to leaving the premises, he shall giveto the owner, operator, or agent in charge a receipt describing the samples.
A. The Board or its agents are authorized upon presenting appropriatecredentials and a written notice as to the purpose of the inspection to theowner, operator or agent in charge to enter at reasonable times any factory,warehouse or establishment in which drugs, devices or cosmetics aremanufactured, processed, packed or held for introduction into commerce or toenter any vehicle being used to transport or hold such drugs, devices orcosmetics.
The Board or its agents are authorized to inspect such factory, warehouse,establishment or vehicle and all pertinent equipment, materials, containersand labeling.
In the case of any factory, warehouse, establishment or consulting laboratoryin which prescription drugs are manufactured, processed, packed or held, theinspection shall extend to all things, including records, files, papers,processes, controls and facilities, bearing on compliance with Chapter 34 (§54.1-3400 et seq.) of this title.
No inspection authorized for prescription drugs shall extend to financialdata, sales data other than shipment data, pricing data, personnel data,other than data as to qualifications of technical and professional personnelperforming functions subject to this chapter, and research data.
Each inspection shall be commenced and completed with reasonable promptness.The Board or its agents shall have access to copy all records of carriers incommerce showing the movement in commerce of any drug, device, or cosmeticand the quantity, shipper and consignee. The evidence obtained under thissection shall not be used in a criminal prosecution of the person from whomobtained; and carriers shall not be subject to the provisions of Chapter 34by reason of their receipt, carriage, holding, or delivery of food, drugs,devices, or cosmetics in the usual course of business.
B. If the authorized agent inspecting a factory, warehouse or otherestablishment has obtained any sample in the course of the inspection, uponcompletion of the inspection and prior to leaving the premises, he shall giveto the owner, operator, or agent in charge a receipt describing the samples.
A. The Board or its agents are authorized upon presenting appropriatecredentials and a written notice as to the purpose of the inspection to theowner, operator or agent in charge to enter at reasonable times any factory,warehouse or establishment in which drugs, devices or cosmetics aremanufactured, processed, packed or held for introduction into commerce or toenter any vehicle being used to transport or hold such drugs, devices orcosmetics.
The Board or its agents are authorized to inspect such factory, warehouse,establishment or vehicle and all pertinent equipment, materials, containersand labeling.
In the case of any factory, warehouse, establishment or consulting laboratoryin which prescription drugs are manufactured, processed, packed or held, theinspection shall extend to all things, including records, files, papers,processes, controls and facilities, bearing on compliance with Chapter 34 (§54.1-3400 et seq.) of this title.
No inspection authorized for prescription drugs shall extend to financialdata, sales data other than shipment data, pricing data, personnel data,other than data as to qualifications of technical and professional personnelperforming functions subject to this chapter, and research data.
Each inspection shall be commenced and completed with reasonable promptness.The Board or its agents shall have access to copy all records of carriers incommerce showing the movement in commerce of any drug, device, or cosmeticand the quantity, shipper and consignee. The evidence obtained under thissection shall not be used in a criminal prosecution of the person from whomobtained; and carriers shall not be subject to the provisions of Chapter 34by reason of their receipt, carriage, holding, or delivery of food, drugs,devices, or cosmetics in the usual course of business.
B. If the authorized agent inspecting a factory, warehouse or otherestablishment has obtained any sample in the course of the inspection, uponcompletion of the inspection and prior to leaving the premises, he shall giveto the owner, operator, or agent in charge a receipt describing the samples.
