The QMN Weekly Bulletin

FDA Slaps Four Supplement Makers With Warning Letters Over Quality Control

May 27, 2016

Four supplement makers were hit with FDA warning letters March 22 over alleged quality control violations and related issues.

The first came from the FDA’s New Jersey District Office and accused VitaCare Pharma of failing to follow federal specifications for ensuring strength and potency of dietary supplements. The March 7 letter, which was posted online Tuesday, claims that two of VitaCare’s products are adulterated owing to GMP issues uncovered during an inspection from Oct. 13 to Nov. 3, 2015, at the company’s plant in South Plainfield, N.J.

According to the inspector, the company didn’t test the ingredient synephrine HCL for potency prior to adding it to its dietary supplements. Similarly, the letter says that VitaCare didn’t test schizandrol A for strength or purity before adding it to another batch of the supplement.

The letter also hit the company for not auditing its suppliers to ensure ingredient potency, and its quality control personnel for not conducting a material review of the Udamin SP tablets. Similarly, the inspector concluded that the company’s batch production records for US Vitamin D3 5000 V Capsules neglected to incorporate the identity and weight of each ingredient.

Lastly, the company was cited for failing to keep proper records of its laboratory methodology.

Herbal Junction

Another warning letter posted the same day accused Herbal Junction of adulterating and misbranding its supplements.

The March 11 letter contends that an inspection of the company’s facility in Eugene, Ore., from May 26 to 29 and June 4, 2015, cited five serious violations.

According to the letter, Herbal Junction failed to establish specifications “for any point, step or stage in the manufacturing process” to ensure quality control or proper packaging and labeling. This includes a lack of component specifications, in-process specifications and finished product specifications.

The letter also contends that the company neglected to establish or follow a master manufacturing record covering all products and batches to ensure batch uniformity.

Another complaint was that Herbal Junction did not prepare a batch production record for each batch of supplements it produces.

Raphah Warning

New Brunswick, N.J.-based Raphah was accused of improperly storing supplement ingredients and in-process materials in a Feb. 26 warning letter posted online the next week.

According to the letter, a September 2015 inspection found several drums of in-process supplements “with multiple handwritten markings on the drums, making it difficult to accurately identify the contents.” Another drum purportedly did not have a lid.

Raphah told the investigator that it lacks written procedures on the requirements for holding and distributing dietary supplements.

The company also was accused of lacking written procedures for calibrating instruments and controls used in its manufacturing or testing.

Herbal Energetics

An FDA inspection of Herbal Energetics/In Joy Organics of Northfield, N.H., apparently turned up issues with quality control operations and responsibilities, according to the Feb. 25 warning letter issued March 3.

The Sept. 23 through Oct. 16, 2015, inspection also concluded that Herbal Energetics lacked contamination limit specifications for heavy metals and filth for a product.

The warning letter cites the firm for failing to establish written specifications to ensure quality control operations and responsibilities. The company’s batch control records also purportedly lacked information such as the identity and weight of each component, and initials of personnel responsible for verifying batch materials were missing.

All the companies were given two weeks to respond with a detailed description of all corrective steps taken.

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