The FDA concluded based on the violations that Physio-Control's defibrillators were both "adulterated" and "misbranded." The regulatory body also said that many of the violations were similar to violations discovered in 1992, 2000, 2003, and 2005.

Earlier this year, according to court documents, the FDA re-inspected the Redmond plant and found that there continued to be violations.

"These deviations involve quality systems... that are critical to ensuring the safety, quality, and reliability of all Physio-Control External Defibrillators manufactured at the Redmond facility," the injunction states.

(Read the injunction, filed in United States District Court, here.)

According to the agreement reached between the FDA and Physio-Control last week, also filed in United States District Court, Physio-Control is banned from selling defibrillators until the company complies with the Federal Food, Drug, and Cosmetic Act and hires an independent expert to conduct inspections, among other remedies.

It is unclear exactly how long it will take Physio-Control to comply with the agreement, at which point it will again be able to sell its defibrillators. However, if Physio-Control does not comply with the agreement it will have to pay a fine of $15,000 per day, in addition to $15,000 per day for each violation.

(Read the agreement, here.)