Top 10 Ways to get an FDA Warning Letter

It’s the question many managers ask themselves as they prepare for their upcoming audit. NSF International conducts hundreds of GMP audits at dietary supplement manufacturing facilities annually.

NSF also supports the dietary supplement industry worldwide by providing expert training on a variety of topics instrumental to understanding regulations and critical to achieving or maintaining regulatory compliance.

Here’s what our highly trained, global network of auditors found in 2016…
The cGMP systems that supplement manufacturers struggled with most last year:

  1. Ensuring that Batch Production Record follows the Master Manufacturing Record and that each step is performed appropriately.
  2. Establishing procedures to prevent pests and animals from entering the facility (installation of screens and barriers, rodent traps, insect traps, lights, etc.)
  3. Properly using equipment and utensils to protect components and dietary supplements from contamination from any source.
  4. Establishing appropriate roles and responsibilities for Quality Control Personnel.
  5. Ensuring walls, floors and ceilings are adequately cleaned and kept in good repair.
  6. Maintaining, cleaning and sanitizing all equipment, instruments, utensils and contact surfaces.
  7. Taking necessary precautions to prevent contamination, such as microbial, filth, chemical and foreign material contamination, throughout the manufacturing process.
  8. Establishing adequate precautions against contamination by microorganisms, chemicals, filth, or other extraneous materials.
  9. Establishing Supplier Qualification Procedures, including procedures for initial qualification, periodic examination (re-qualification) and disqualification.
  10. Establishing procedures and programs for maintenance of equipment.

Why Mentality Matters When Training for a Sport

Author: Jorge Montano

You’ve probably heard the importance of “getting your mind right” before training for a sport, but there can’t be any harm in letting it slide every once and a while right?

Not quite.

Your mindset can hurt or help you — here are just a few examples:
• It has the ability to either make or break you long term
• It will allow you to push harder and not quit
• It will give you endurance to sustain you.
• Your body gives up way before your mind does
• When your mind changes you change your results

Sports psychologists say that 90% of your performance is mental. With that being said, we believe that your mental preparation when training for a sport is of the utmost importance. Your mind is one of the most potent aspects of your being and will either be your greatest asset or your biggest setback. Your mentality makes up your beliefs about yourself –whether you’ll go the extra mile, be consistent with your diet, or quit when the going gets tough when training for a sport.

The Benefits
The benefits of sharpening your mentality for a sport are well documented. Studies show that when athletes practiced mindfulness before competitive situations, they showed greater adaption to stressful situations during their actual competitions. [1] Greater adaption to stress means being able to train harder, better, faster, stronger – cue in Kanye West.

There are psychological rigors that come with the territory when training for a sport or competition. Here are two easy, but powerful techniques to help increase your mentality within your sports training regimen to help maximize your performance.

Visualizations – See yourself on top and you’ll likely stay on top. Keep your mind focused on who you want to become and not on your shortcomings.

Affirmations – This is a great way to keep those visualizations alive. For example, instead of saying “I’m not strong enough” focus on who you want to become. For example say, “I AM strong.”

Exercising your mind, like the body, will give you amazing results. Strengthening the mind-body connection will give you a definite edge when training for any sport.

Eating For Your Fitness Goals: Why It Matters

Author: Jorge Montano

You are what you eat. You’ve heard the saying before, but when you exercise regularly, you don’t need to worry as much because you’ll eventually burn everything off right?

Wrong!

What you eat still matters at the end of the day, especially when it comes to hitting your fitness goals. This post will give you some insight as to why it matters to keep sticking to your meal plan even when you’ve been hitting the gym everyday.

Your body breaks down everything into three big macronutrients: fats, carbs, and protein. These macronutrients are needed in very large amounts in your body and will only get them from the food that we eat. If you are not eating what your body needs, how can you expect it to perform at optimal levels? It won’t. This is where proper nutrition comes in. When you keep a balanced diet, you are allowing your body to effectively use the foods that you eat to replace protein, fuel you muscles, increase your metabolism, and even promote functions on a cellular level.

When you eat whatever you want, you most likely are not eating a balanced diet. For example, a can of soda is filled with simple carbs that your body breaks down and uses immediately. Your body further breaks down these carbs into another sugar called glucose – the body’s main source of fuel. Since soda is filled to the brim with excess sugars your body does not need, your body stores that sugar as fat. You heard right! Excess sugar is always stored as fat. When you are mindlessly eating, it’s usually with junk foods that have very little, if any, nutritional value. You won’t get full off of these foods and will overindulge, which will definitely not help you reach your fitness goals.

In the long run, it’s always important to stick to nutritionally dense meals as your main source of food and gain an understanding as to how they will break down into your body overall. This doesn’t mean you need to eat salads everyday, but you do need to practice mindful eating. Practice being aware of the food you put into your body and maximize your fitness results.