Call Us Toll Free (800) 688-5956

FDA still finding same cGMP deficiencies at dietary supplement facilities

04_06 FDA s9 resize

FDA investigators who inspect dietary supplement manufacturing facilities for compliance with cGMPs (current good manufacturing practices) are still often finding the same deficiencies more than a decade after the regulations were adopted.

In fiscal year 2018 (FY18), 75 inspections—or about 24 percent of firms that received a Form 483 inspection report for “observations,” or alleged cGMP violations—were cited for failing to establish product specifications for the identity, purity, strength and composition of the finished dietary supplement, FDA data revealed. This was the most common cGMP observation in FY18 year as well as in FY17 when 24 percent of firms (89 inspections) were cited for the same infraction, according to FDA data INSIDER obtained through the Freedom of Information Act (FOIA).

Over the years, FDA has repeatedly emphasized the importance of setting and following specifications for the identity and other key attributes of a dietary supplement. Without doing so, FDA and outside cGMP consultants have said, manufacturers have no reliable way to know and verify what is in their products.

Nearly half (274 inspections, or 46 percent) of the 591 inspections in FY18 didn’t receive a Form 483, which suggests those dietary supplement manufacturing facilities are fully compliant with the cGMPs.

Warning Letters

There may be another silver lining. Data analyzed by the Natural Products Association(NPA) suggested an increasing number of firms cited in Form 483s for failing to establish product specs make the necessary corrections without requiring an admonishment from FDA in a subsequent warning letter.

NPA, a trade association founded in 1936 and led by former FDA officials, reviewed FDA warning letters to analyze alleged infractions of the cGMPs.

In reviewing the data dating back to 2010, NPA identified a change in the most cited cGMP violation. Through the first nine months of 2018, FDA most commonly cited dietary supplement firms in warning letters for failing to establish and follow written procedures for the responsibilities of quality control operations. In FY18 Form 483s, the latter cGMP infraction was the second most cited cGMP observation (52 inspections, representing around 16 percent of all Form 483s).

In the previous three years, the most common cGMP violation reported in FDA warning letters was related to specifications to establish when devising a production and process control system, NPA reported this week in a chart within a news release. The above infraction dropped to the third most-cited cGMP violation in 2018 warning letters, while the second most commonly cited infraction related to recordkeeping requirements for production and process control systems.

Read The Full Article HERE

Related Post

NutraCap Labs

About NutraCap Labs

OUR MISSION:
NutraCap Labs’ mission is to provide our customers with the highest quality products and an industry-best customer service experience. Based in Atlanta, GA, NutraCap Labs is a manufacturer of Nutraceuticals/Dietary Supplements and we are experiencing explosive growth. As a GMP compliant and an FDA registered company, we specialize in encapsulation manufacturing, sports nutrition and raw health powders, product formulation, brand design and distribution. Private Label manufacturing is the fastest growing sector of our business and our biggest strength due to the relationships we have built with our customers.

OUR GOAL:
Our goal at NutraCap Labs is to partner with our customers to create the best products possible through custom formulation, in-house label design and other services that we offer. Additionally, through our sister company, Active Sports Distribution, we market and sell some of the health and fitness industry’s most popular supplements to retail stores worldwide. With the Nutraceutical industry approaching $85 billion annually, we are excited to become a leader in this arena. Our experienced management team is committed to bringing ethics and professionalism to the forefront of the industry.

At Nutracap Labs we aim to lower what has always been a high barrier to entry into the dietary supplement industry. Our minimums start at 144 units per product and allows lower risk for two categories of customer. 1. Those who may be working with limited capital and cannot tolerate much risk. 2. Those who have the capital but are interested in testing the market before they scale their business

No Comments

Leave a Comment

dcl-made-in-usa
dcl-fda
dcl-gmp-certified
Nutracap-Organic-Seal
Nutracap-asi

For more information call (800) 688-5956 or Contact Us for a Free Quote!

For a Free, NO HASSLE Consultation or Quote: Simply fill out the form below and Click Send. One of our friendly staff will reply to you promptly. Thank you!