24.01.24

Failure to Respond to Multiple FDA Requests leads to Warning Letter

Not responding to FDA requests for records related to drug manufacturing and product quality is not a good idea, as can be seen by a recently published Warning Letter.

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24.01.24

FDA Warning Letter to Turkish Manufacturer of Drugs, Cosmetics and Detergents

Even with increasing distance to the pandemic situation, manufacturers of disinfectant products still seem to be relying on less stringent controls. After a large number of Warning Letters regarding hand sanitizers with contaminated or poorly analyzed products in the Americas and Southeast Asia, a Turkish company is now affected. The company Sudesan in Istanbul received a Warning Letter from the FDA listing several deviations.

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06.12.23

FDA Warning Letter: Inadequate Testing of BZK and Many General GMP Violations

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter. Beside a whole series of general GMP violations, the authority in particular blames the company for failing to test the incoming component benzalkonium chloride (BZK).

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25.10.23

FDA Warning Letter for South Korean Manufacturer: Identity Testing, QU Oversight, Equipment Qualification and Maintenance

The U.S. Food and Drug Administration (FDA) has sent a new Warning Letter to a manufacturer located in South Korea. The firm manufactures over-the-counter (OTC) topical drug products, such as hand sanitizers. During an inspection, significant violations of Current Good Manufacturing Practice (CGMP) were found.

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18.10.23

Three FDA Warning Letters due to Unanswered Requests for Records

The U.S. Food and Drug Administration (FDA) has issued three somewhat similar Warning Letters. The companies concerned had each failed to respond to requests for records and other information.

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04.10.23

FDA Warning Letter for OTC Manufacturer in Arizona

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to a U.S. OTC manufacturer. During an inspection, several CGMP violations were found.

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23.08.23

Series of FDA Warning Letters due to inadequate Testing of Glycerin and Other High-Risk Drug Components

Just recently, we reported on a Warning Letter regarding a manufacturer who failed to conduct proper identity testing of glycerin and other high-risk components. The FDA has now published a whole series of Warning Letters that revolve around the same topic.

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26.07.23

FDA Warning Letter: Using non-validated and not appropriate Test Methods from an Internet Search is not a good Idea

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter. The company in question manufactures over-the-counter (OTC) topical drug products, e.g. antibacterial hand soaps and hand sanitizers. The list of GMP violations is quite extensive and concerns, among others, QU oversight, handling of out-of-specification (OOS) results, identity testing, and laboratory controls in general.

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12.04.23

FDA Warning Letter to Californian Drug Manufacturer

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to a drug manufacturer in California. The FDA blames the company of various CGMP violations, particularly in the areas of release testing, sampling, stability testing and process validation.

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22.03.23

Fundamental GMP Deficiencies at Disinfectant Manufacturer

Due to numerous and fundamental GMP deficiencies, the FDA has issued a Warning Letter to a manufacturer of over-the-counter antibacterial hand soap, antiseptics and hand sanitizer in Puerto Rico.

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