FDA says Turkish OTC maker’s testing program earns failing grades

Regulatory NewsRegulatory News | 08 September 2021 |  By 

The US Food and Drug Administration (FDA) criticized a Turkish manufacturer of over-the-counter drugs for failing to test incoming ingredients and to test products before releasing them to the market in a recent warning letter. The company was also warned for its lax approach to stability testing.
The 13 May letter to Istanbul-based Gulsah Uretim Kozmetik Sanayi Anonim Sirketi follows up on FDA’s review of a 23 April response to request for records. The firm is the latest manufacturer warned of good manufacturing practice (GMP) violations that are based solely on a review of records and not an onsite inspection. (RELATED: FDA’s document-based inspections prompt warning letters for GMP violations, Regulatory Focus, 13 April 2021).
FDA said the firm failed to test batches of products prior to release to ensure that active pharmaceutical ingredients (API) conform to “appropriate laboratory determinations” for identity and strength. The company had replied that this release testing was not required “because the formulation is stable.”
In response, FDA reminded the firm that “without adequate testing, there is no scientific evidence to support that your drug product batches conform to the label claim prior to release.”
The company also failed to test and verify the identity of each incoming component of a drug product, and to validate and establish the reliability of their component supplier’s test analyses at appropriate intervals. The firm also released an API for use in the product based on the analysis report of a component supplier without validating the reliability of the supplier’s analysis.
FDA also said the firm failed to establish and follow a written stability testing program to determine appropriate storage conditions and expiration dates.
The agency said the firm’s data “did not demonstrate that the drug’s active ingredient is stable throughout its shelf life. Further, the data provided did not include testing for degradation products.”
FDA reminded the firm that “without appropriate stability data, you cannot ensure your drug products meet established specifications and all pre-deteminrted quality criteria throughout the drug product’s assigned shelf life.”
The company was advised to hire a GMP consultant and to respond to the warning letter within 15 working days of receipt.
Warning letter


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Tags: drugs, FDA, letter, OTC, warning

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