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In the fictional storyline, the Prime Directive was created by Star Fleet and the United Federation of Planets shortly after they were first formed.
Since then the Prime Directive has been breached on many occasions, both accidentally and deliberately.
Sometimes when a Federation starship or vessel crashes on a planet that has a pre-warp civilization, the survivors or the wreckage are collected by the natives, and this then influences their society, especially when Federation technology is recovered and added to the technology of the planet.
Sometimes the Directive is deliberately violated.
Circa stardate 2534. 0 ( 2266 ), in the Original Series episode " Patterns of Force ," cultural observer and historian John Gill openly created a regime based on Nazi Germany on a primitive planet in a misguided effort to create a society which combined what he ( mistakenly ) viewed as the high efficiency of a fascist dictatorship with a more benign philosophy, thereby contaminating the normal and healthy development of the planet's culture.
Much to his regret, the intervention proved disastrous with a power-hungry subordinate making Gill his puppet and causing the regime to adopt the same racial supremacist and genocidal ideologies of the original, forcing Star Fleet personnel to intervene directly to minimize the harm to the societies.

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