Inspection factories

A revision of the Pure Food and Drug Act, the Federal Food Drug and Cosmetic Act, passed in 1938, added several provisions that impacted the food industry. Among those provisions were authorized factory inspections and the authority for court injunction to the previous seizure and prosecution actions (Janssen, 1992). Adulterated food was now defined as Sec. 402, A food shall be deemed to be adulterated if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food, or if it has been prepared, packed or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. The importance of the whereby clause is the concept that a food product need not be contaminated physically to be considered adulterated, but has been exposed to conditions that may have resulted in contamination of the food. This situation is vastly different from that which existed at the time the 1906 Food and Drug Act was passed. 

Licensing may come sometime, Campbell wrote after the new law had gone into effect, but the climate was not right for it in 1938 (90). "Meanwhile, there seems no alternative. . . except to undertake, through the gradual development of powers that have been conferred upon us by. . . section 505 and the authority to make factory inspections, a more effective regulation of the production and marketing of pharmaceutical products than was possible under the old statute.. .."... 

The Factory Inspection Amendment clarifies FD C and requires FDA to provide written inspection... 

Evaluating through factory inspections, including the collection and analysis of associated samples, the conditions and practices under which drugs and drug products are manufactured, packed, tested, and held, and... 

Instrument factory inspection and calibration must define what is required to verify compliance with the instrument data sheet. It should cover ... 

FDA is required to provide notice of finding in factory inspections and analyses of samples. 

Therefore, if a farmer or food manufacturer holds an organic production licence it shows that an independent organisation has visited their farm or factory, inspected their production/processing practices, and is satisfied that they comply with an established... 

The United States has two nationally accepted codes the National Fire Protection Association s Lightning Protection Code (ANSI C5. 1), and the Underwriter s Laboratories Master Labeled Lightning Protection System (Standard UL 96A). The requirements of these two codes are quite similar and are probably equally utilized on structures throughout the nation. The major difference between the two is that the Master Label can be certified upon both a factory inspection and labeling of the lightning protection materials and upon performance of a field inspection by an authorized inspector. 

U.S. Federal Food, Drug, and Cosmetic Act, Section 704, Factory Inspection. 

Factory Inspection Amendment required FDA to give manufacturers written reports of conditions noted during inspections. 

The TSA also recognised that the competence of the manufacturer s employees and the conditions under which they worked were as important as the tests applied to the end products. Factory inspections and in-process control therefore played a large part in supervision by the Licensing Authority. Records of sale also had to be kept by the manufacturer, and the container had to identify both the manufacturer and the batch. 

In U.S. versus Cardiff, the Supreme Court rules that the factory inspection provision of the 1938 FDC Act is too vague to be enforced as criminal law. 

With most specifications there are some key aspects that should be clearly stated or defined, the omission of which can cause embarrassment, delay and extra costs at a later date e.g. at the factory inspection, during installation and commissioning. A well-designed data sheet to accompany the specification will do much to avoid ambiguity or the omission of requirements. The data sheet should comprise two parts, a part completed by the purchaser to define the requirements and a corresponding part for the manufacturer to state what is offered. 

The Durham Humphrey Amendment (1951) defined the kinds of drugs that required medical supervision for safe use and restricted them to sale by prescription. Two years later, in 1953, the US Public Health Service issued a policy document entitled Group Consideration of Clinical Research Procedures Deviating from Accepted Medical Practice or Involving Unusual Hazard. This policy stated that the potential risks of clinical studies must be carefully assessed and that informed consent was essential. Ethical review of research proposals was also suggested. In this same year, the Factory Inspection Amendment was passed, requiring the FDA to give written inspection reports to manufacturers. 

BASF Archives, C 11, Meeting of the Central Committee of the Supervisory Board of May 21, 1919 see ibid.. Supervisory Board meeting of March 1, 1919. As to the success or failure of this whole espionage business, one can only speculate. It can however be assumed that the factory inspections in conjunction with BASF s foreign patent applications that were impounded during the war were, at the least, no hindrance to... 

UL is an example of an approval laboratory that industry and the government depends on its exceptionally qualified performance. It identifies a product which has been produced under UL s classification and follow-up service and which bears authorized classification marking of UL as the manufacturer s declaration that the product complies with UL s requirements. The UL s Laboratory Factory Inspection involves visits by a UL s representative to a factory or other facility. Purpose of conducting the examination and/or tests of products is to ensure compliance with UL approved requirement. The examination is the means that shows how the manufacturer exercises its operation to determine compliance with the UL s requirements. 

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