Beware of Repeat 483 Violations

Beware of Repeat 483 Violations

April 4th, 2013 // 3:14 am @

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We came across this week a warning letter dated March 18, 2013, issued by FDA to Keystone Laboratories in Bozeman, Montana. This cosmetics manufacturer was cited for a number of fairly significant GMP violations.

The company didn’t maintain its buildings in a good state of repair used for manufacturing, processing, packing and holding of drug products. The company had condensate leaking into a plastic bucket that was tied to the ceiling in the production area. There also was peeling pain on the floors, support beams and walls of the production room.

The warning letter then noted the key words: “This is a repeat observation from our 2009 and 2011 inspections.” So, these rather basic observations – a manufacturing facility kept in poor repair – was an observation made on TWO previous occasions.

As our Webinar speaker Dennis Moore stated in March, if you have repeat 483 observations, especially the same 483 observation several times, you are begging for trouble! FDA is going to take enforcement action on you, and it usually will start with a warning letter. That is exactly what happened to Keystone Laboratories here. So, rather than correct a fairly basic 483 observation after two warnings, Keystone now has the public relations problem of a warning letter.

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Let us be very clear: DO NOT let this happen to you! If you get a 483 observation, provide FDA with a clear plan of action to fix the problem, and then follow up and do it! Repeat observations lead to warning letters.

Next, Keystone Laboratories did not use equipment that was of the proper design or adequate size or properly located for its intended use, and for its proper maintenance and cleaning. For instance the firm uses wood sticks in processing and cardboard covers are used on its production equipment. The sticks come in contact with drug products and the cardboard is then used on the equipment to cover up open product while processing is going on. The materials are not made for drug manufacturing and they are impossible to clean. This means that they can become contaminated with microbes and dirt that affect quality.

Also, the lab did not clean, maintain and sanitize or sterilize equipment at the right intervals to stop malfunctions or contamination. There were scratches and rest stains in containers used to mix and measure drug products. And there was equipment and utensils with filth and obvious build up. There also was a lack of documentation to show the equipment was being cleaned regularly. This also was a REPEAT observation from 2009 and 2011.

At the end of the letter, FDA made a special note about the poor quality control at the company, which to us is a warning of future actions. In FDA’s view the firm’s QC department is not doing its job and may not possess the authority to do its job. FDA recommended they start to work with a third party consultant ASAP to fix the problems. This is a strong indicator that FDA is going to drop the hammer on this company if they don’t clean up their act.

We all know that FDA is not always easy to please in an inspection. However, this company was almost asking for a warning letter for not properly following up on several repeat 483 observations.

When you are responding to FDA and its observations, do not promise the moon. If you can’t get something done in 30 days, then do not promise it. Be realistic in your response about how much time you will need to fix a problem. But do make sure that you respond quickly and take care of the observation so that no further action is warranted from the agency.

Again, ALWAYS follow up promptly with FDA on 483 observations so that you minimize the risk of a company-damaging warning letter.


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