Avoiding FDA 483s Strategy #5: Don’t neglect your physical plant

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Avoiding FDA 483s Strategy #5: Don’t neglect your physical plant

By | 2016-07-12T12:47:24+00:00 August 20th, 2013|CGMP, cGMP Quality Assurance and FDA 483s, FDA, FDA Inspections, Form FDA 483|

Meridian Medical Technologies was cited when inspectors saw a something “which appeared rust-like…on the bottom of the stainless steel plate located across the top of the window in Room [b] in the class [b] area where EpiPen NGA is manufactured.”

manufacturingVentilation problems. Rust on the walls. Drips in the pipes. Not only are these ugly, they’re going to get you cited. You may know this, and your quality team too, but sometimes small mechanical or functional problems get ignored or minimized.

Worse, some companies don’t take these problems seriously even when they’re noted by the agency. If an inspector comes through and complains that a door doesn’t shut right, don’t say, “oh yeah, that’s true,” warns one senior DC attorney who works with FDA issues. “Wrong answer!” he says. “You’ve got to say, ‘you’re right, and we’re sending maintenance over today to fix it.”

One former compliance official used a simple test to get a sense of how seriously companies took having a clean operation: he’d walk into the men’s room and check it out. “If it isn’t clean in there, how can you be making a good product?” the official says.

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