Most of us may recognize that the FDA has instituted Quality Management and Quality Systems regulations largely to control shipment of medicinal products between states and importing to the US. These regulations now ensure a minimum level of quality for pharmaceutical, biotech and medical device products that reach the consumer.
A great many observations from Inspectors in the past few decades have pointed to one or more quality systems being out of control leading to “Adulterated” or “Misbranded” product from the offending party. The general definitions for these terms, not specific to the FDA or regulations, are as follows:
Adulterate: to make (something, such as a food or drink) impure or weaker by adding something of poor quality.
Misbrand: to brand falsely or in a misleading way; specifically: to label in violation of statutory requirements.
The following are direct quotes from recent Warning Letters from FDA inspectors regarding adulterated product observations:
“FDA investigators also noted CGMP violations at your facility, causing the drug products for which you have not obtained valid prescriptions for individually-identified patients to be adulterated…”
“This inspection revealed that these devices are adulterated…, in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation…”
“FDA investigators observed that your drug products that were intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing these drug products to be adulterated…”
“Your firm failed to establish product specifications for each dietary supplement that you manufacture for the identity, purity, strength and composition of the finished batch of the dietary supplement, and for limits on those type of contamination that may adulterate or that may lead to adulteration of, the finished batch of the dietary supplement…”
“Your product is misbranded… because the labeling fails to bear the common or usual name of each ingredient contained in the proprietary blend…”
While the specific observations vary somewhat, we know these two points for certain:
Mismanagement and poor implementation of Quality Systems leads to products being defined by the FDA as “Adulterated” or “Misbranded".
Many Warning Letters in the recent past have been issued due to poor packaging and labeling practices, which could lead to misbranding findings.
But what if everything goes right in manufacturing and packaging? What is the next step for misuse of product either intentionally or unintentionally by the consumer? The Industry only holds control of the finished product until it reaches the home of the patient, or trial participant.
One major organization has been putting great effort into educating the populace on difficult to read or understand labelling: The United States Pharmacopeia (USP).
From these outreach campaigns and articles, the USP is making it clear that fraudulent, low quality, adulterated and difficult to use products will not be tolerated by government agencies and consumers.
There are so many points from manufacture to administering where the product or the product packaging can fail. Could this be a lack of effort from the consumer to learn about the products they are using? Does the onus lie solely on those responsible for the labeling, including warnings and directions for use?
What we do know for certain: if we strive to achieve the highest quality, personally and professionally, we can limit variations and violations, making our industry safer every day.
FDA Website - Inspections, Compliance, Enforcement, and Criminal Investigations section: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm
Article: Do You Find Prescription Labels Hard to Read? You are not alone. Anne Bell posted on 8/12/2014.
Article: 5 Tips to Avoid Adulterated Products Marketed as Dietary Supplements, USP Staff posted 7/22/2014.
Compliance Insight, Inc. Presentation - Warning Letters: A Compliance Officer's Guide to Surviving the Storm by Troy Fugate, published May 30, 2013.