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U.S. Department of Health and Human Services

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Volume III - 5.1 Historical Background and the Law

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Other Laboratory Operations

Food and Drug Administration

DOCUMENT NO.:

III-05

VERSION NO.:1.5

Section 5 - Analysts on Inspection

EFFECTIVE DATE: 10/01/2003REVISED: 01-30-13

FDA's primary duty is that of a domestic public health agency charged with the protection of the health of American consumers with regard to the safety and efficacy of foods, drugs, cosmetics, biologics, medical devices and radiological products. 

The Agency's statutory requirements, defined primarily by the Food, Drug, and Cosmetic Act, (FD&C Act) were promulgated to ensure that consumers are protected against unsafe products, and from the adverse health or economic consequences of false or misleading labeling. This is often accomplished by an inspection of the facility. FDA's authority to conduct an establishment inspection is found under Section 704 of the Act: http://www.fda.gov/opacom/laws/fdcact/fdcact7a.htm

  • SEC. 704. [374] "employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized (A) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, or cosmetics in interstate commerce; and (B) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein.

    A separate notice shall be given for each such inspection, but a notice shall not be required for each entry made during the period covered by the inspection. Each such inspection shall be commenced and completed with reasonable promptness.

    Upon completion of any such inspection of a factory, warehouse, consulting laboratory, or other establishment, and prior to leaving the premises, the officer or employee making the inspection shall give to the owner, operator, or agent in charge a report in writing setting forth any conditions or practices observed by him which, in his judgment, indicate that any food, drug, device, or cosmetic in such establishment (1) consists in whole or in part of any filthy, putrid, or decomposed substance, or (2) has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health."

21 Code of Federal Regulations (CFR) 113 and 21 CFR 114 requires commercial processors of LACF and acidified foods to maintain complete records of processing, production, and initial distribution of these food products.  21 CFR 108.35(h) and 21 CFR 108.25(g) provide that a commercial processor shall permit the inspection and copying of these records by duly authorized employees of the FDA. http://www.gpoaccess.gov/cfr/index.html. The Demand for Records (FDA 482a) must identify the specific records requested and must be signed by the investigator.  It should be noted that FDA inspections do not extend to financial data, sales data, other shipment data, and research data (other than data for drugs, antibiotics, and reporting)

  • Review associated Guidance Documents.
  • Read the hard copy or FACTS inspectional assignment to determine what is to be covered.
  • Review the File Jacket for the previous inspection(s); note previous deficiencies and if there were corrective actions.
  • Review previous EIRs and 483s.
  • Review the assigned Compliance Program.
  • Review the related sections of the CFR.