OTC makers hit with US FDA warning letters

By Staff Reporter

- Last updated on GMT


Related tags Import alert Pharmaceutical drug Food and drug administration

Two Chinese and one Korean over-the-counter (OTC) drugmakers have received US FDA warnings for violating good manufacturing practice (GMP) regulations for finished pharmaceuticals.

The US Food and Drug Administration (FDA) published the three letters last week.

The most recent was sent on February 2 to Cosmecca Korea Co. Ltd, following an inspection at its Chungcheongbuk-do facility in September last year.

Among the violations noted in the letter are allegations on falsified data and failures in carrying out adequate product testing.

“Your OTC sunscreen drug product, (b)(4), contains (b)(4) active ingredients: (b)(4). Your batch records for lot (b)(4) of this product included concentration values for these active ingredients that did not match the data found in your instruments. You used the inaccurate data reported in your batch records to calculate potency results that were within specification, and you relied on these inaccurate results to release your product,” the letter​ states.

“Our investigator found that you failed to test incoming active pharmaceutical ingredients used to manufacture finished products for the United States using the U.S. Pharmacopeia (USP). Your specifications allow a higher level of impurities, such as (b)(4) and (b)(4), than the limits established by USP.”

On January 8, the FDA placed the firm on Import Alert 66-40 – ‘Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs.’

Guangzhou Baiyunshan Pharmaceutical Holdings

Guangzhou Baiyunshan Pharmaceutical Holdings received its letter​ on November 1, following an inspection in May last year.

Issues raised by the FDA included cleaning and contamination-risk at the firm’s facility in Guangzhou, China.

“Our investigator observed a (b)(4), identified and approved as clean, that contained a significant amount of (b)(4) material and product residue. This particular (b)(4) is used for two different (b)(4) products. In your response, you blamed your employees for exercising poor discipline when cleaning the (b)(4).”

The FDA also noticed formulation and labelling concerns at the plant.

“During the FDA inspection conducted on May 22–25, 2017, our investigator reviewed and directly observed your firm’s microscopic analysis for identification of (b)(4) materials in a recently manufactured batch of (b)(4). The label for (b)(4) does not declare these (b)(4) components. Your firm advised that the concentrations of these ingredients were low and medically ineffective. As you were advised during the inspection, all ingredients, whether active or inactive, must be declared on product labels.”

The firm was placed on Import Alert 66-40 in October last year.

Jiangmen Nowadays Daily Goods

The third OTC maker to have its warning​ published last week is Jiangmen, Guangdong-based Jiangmen Nowadays Daily Goods.

“You released your over-the-counter (OTC) drug products, such as (b)(4) and (b)(4), without adequately testing them for conformance to specifications, including identity and strength,”​ the FDA said following an inspection in March 2017.

Furthermore, the Agency said the firm failed to test incoming APIs used to manufacture OTC drug products to determine their identity, purity, and strength. “Instead, your firm relied solely on certificates of analysis from unqualified suppliers.”

The FDA placed the firm on Import Alert 66-40 on June 7, 2017

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