Dietary Supplement GMP Sanitation Citations

I’ve seen a lot of dietary supplement manufacturing facilities in my life, and within a few minutes you can usually determine how seriously a company takes GMPs.

In this warning letter, a supplement manufacturer received several GMP-related 483 violations. Today, I’ll focus on sanitation issues.

From warning letter. “all hand washing was performed in the employee restroom, as the (b)(4) hand washing facilities in the hallway outside the supplement packaging rooms were full of bins, utensils, and other materials, and were not available for hand washing.”

Asa comments: Facility design is important. It is common for dishes to pile up in a sink, but I am surprised there isn’t a separate hand-washing station. Also, I don’t think an FDA visit is a good time to let dishes pile up.

From warning letter. “An employee reached into a bin containing the above RTE dietary supplement and her bare arms came in direct contact with the powder. Examination of the employee’s arms afterwards indicated an extensive amount of powder adhered to her arms.

Asa comments: Proper gowning is essential, and getting powder “all over” is common in manufacturing. This is why having the right type of gown and/or arm covers available and ensuring the product manager understands the basics of sanitation is important. This means the company owner needs to invest in the correct PPE, and staff need to understand when and where to use it. When in doubt, overgowning is not a bad thing.

From warning letter. “Employees working with the above product were observed wearing jewelry and their street clothing.”

Asa comments: Street clothes are not necessarily a problem unless they can contaminate the product, which is why proper PPE (gowning, footwear, hair nets, masks) is critical. Also, hygiene SOPs should state that jewelry should be removed or taped to ensure it does not fall into the product. I learned this the hard way after someone’s earplug fell out during a powder run, which led to stopping the product line and a lot of rework.

From warning letter. “A batch production record (BPR) contained a statement in the “Notes Continued” section that an employee, “is taking regular breaks; he is sneezing and coughing quite a bit. Had him take some medication for it, but it remains an issue. Having to go slow again.” You did not take appropriate corrective action when an employee was noted to be ill.”

Asa comments: This one is an OMG. Sure, documenting employee illness is fine, but it’s bewildering that this would be in a BPR without a closeout. Any FDA inspector would see this and keep digging.

What are some of your sanitation nightmare stories?

Read the warning letter.