The facts
On October 5, 2026, the FDA issued warning letter MARCS-CMS 734538 to Mr. Earl Lawson, President of Silgan Dispensing Systems, 1001 Haxall Point, Suite 701, Richmond, VA, and posted it to the FDA website on October 13, 2026. The letter covers an inspection of the company's drug manufacturing facility, Silgan Unicep Packaging, LLC, at 4122 South Grove Road, Spokane, Washington, conducted from March 26 to April 2, 2026. The firm contract manufactures non-sterile over-the-counter drug products.
In November 2025, the company obtained out-of-specification microbiological results for component lots: one sample from each lot exceeded the acceptance criterion for total yeast and mold count. The letter states the company "did not perform an appropriate investigation into the OOS results. Rather, you invalidated the OOS results by averaging the (b)(4) total yeast and mold count sample results to obtain a passing result." It also revised its microbiological sampling plan to allow averaging of test results going forward, a practice the FDA calls unacceptable because it "obscures the detection of non-uniform microbiological contamination within a lot." The company subsequently released the lots and used them in manufacturing.
Meanwhile, a customer had initiated a Class I recall of lots manufactured at the facility "due to potential fungal contamination" The FDA rejected the company's response: "Your response is inadequate. You limit the retrospective review to documented OOS events"
A separate section of the letter finds the company was marketing products as drugs through its product labeling and website with no approved applications in effect, making them "unapproved new drugs" whose introduction into commerce violates sections 301(d) and 505(a) of the FD&C Act. On July 22, 2026, FDA held a teleconference with the company recommending that it recall drug products in distribution. The letter closes the section with: "We acknowledge your commitment to suspend production of all drugs at this facility."
Our take
Fuck me sideways, this is the most pathetic, lazy-ass fraud in the history of making shit people put in their bodies. You got moldy components? Don't you dare investigate, you absolute prick - just pull out the fucking calculator and average the failing score with the passing ones. Problem solved! The FDA had to sit down and write a letter explaining to grown adults that microbiology isn't a fucking math quiz where you get to curve your own grade. This isn't sophisticated crime; it's the intellectual equivalent of a toddler covering their eyes and declaring themselves invisible. What a pack of useless, corner-cutting cunts. And while they were busy failing fourth-grade statistics, a customer had to initiate a Class I recall for 'potential fungal contamination' because, shocker, the fungus gives zero fucks about your spreadsheet. It's like using a fucking abacus to fight a bacterial infection. Meanwhile, these greedy dickheads were running a full-on unapproved drug bazaar on their website, because why stop at one regulatory felony when you can commit two? 'Fail at the legal drugs, sell the illegal ones' should be carved on the forehead of every executive in that Richmond office. Their big solution? A 'commitment' to stop making all drugs at the facility. No shit, you mold-brained bastards - you've proven you're about as qualified to manufacture medicine as a dog is to perform fucking neurosurgery. The only thing that should be suspended is their corporate charter, straight into a woodchipper. What a disgraceful, greedy circus of incompetence. I hope their next 'averaged' result is the collective IQ of their leadership team, because I'm betting it’s a solid, undeniable zero. Fucking clowns.
