WASHINGTON—FDA issued a warning letter to New York-based NYSW Beverage Brands Inc. on Jan. 7, 2015, citing the company’s failure to resolve current good manufacturing practice (cGMP) violations. According to the warning letter, FDA audited the company’s Halcott Center facility June 4 to 25, 2014 and found the company misrepresented multiple supplement products as conventional foods; additionally, NYSW and its president Richard Zakka allegedly did not provide adequate responses to cGMP violations such as lacking documentation and relying on supplier-provided specification sheets.
The numerous cGMP violations included failing to:
- Establish product specs for each finished batch of the dietary supplement;
- Establish identity and component specs;
- Follow written quality control procedures required by 21 CFR 111.103;
- Prepare and follow a master manufacturing record (MMR) for each supplement formulation; and
- Prepare a complete batch production record for every manufactured batch.
Throughout the letter, FDA acknowledged NYSW’s June 25 response … but not very well. For example, the company noted it receives a pre-batched syrup from its supplier, and thus used the supplier’s specification sheets. FDA’s response? “Reliance on the specification sheets provided by your supplier is insufficient to meet these requirements, and as such, your response is inadequate."
FDA also stated NYSW misbranded three of its products: “VBlast Tropical Punch," “VBlast Gator Pit Energy Formula" and “VBlast Pomegranate + Cherry." FDA noted, “The products do not include a statement of identity as a ‘dietary supplement’ as required by 21 CFR 101.3(g)." Additionally, the company did not include multiple ingredients on the label and failed to list the function of several chemical preservative ingredients.
NYSW Beverage Brands surely isn’t the natural products company receiving such warning letters. Be sure to visit our Warning Letter Immersion Center, which keeps you up to date on FDA’s notices and the most common violations.