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The ECA regularly reports on FDA Warning Letters that are published on the FDA website following an FDA inspection and that reveal corresponding deficiencies. Below is an overview of ‘bizarre’ findings by the FDA, particularly from the last year.

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In July, the FDA published a warning letter to Exela Pharma Sciences, which, in addition to deficiencies in microbiological tests and inspections such as sterility tests, growth promotion tests and environmental monitoring, also included a whole series of other deficiencies. It was the consequence of an inadequate response to the FDA's previous 483 letter.

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When reading an FDA Warning Letter, you might have recognised that under GDUFA programme, the facility may be eligible for a so-called Post-Warning Letter Meeting. But what is this?

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The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to an Indian contract testing laboratory. Investigations of out-of-specification (OOS) results lacked adequate scientific rationale, and new test results were used to invalidate prior OOS findings without sufficient justification. Furthermore, FDA investigators discovered torn and discarded original CGMP documents in the facility's waste disposal area, and electronic data had been improperly altered or deleted.

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Inadequate root cause analyses are and will continue to be an issue during FDA inspections. A Warning Letter has now been sent to a company in India in this regard.

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In a recently published Warning Letter, the U.S. Food and Drug Administration (FDA) outlined systemic failures in stability testing, storage practices, material testing, finished product release, and water system control at a facility in Utah. During the inspection, the company voluntarily submitted a written statement indicating that it would discontinue the manufacturing of various drug products.

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During an inspection of a US manufacturer of OTC products in March 2025, the FDA identified serious violations of GMP requirements for finished medicinal products. Among other issues, the manufacturer had purchased the water for its production from a grocery store. This resulted in a warning letter from the FDA. Continue reading.

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Since 07 July 2025, three new draft guidance documents have been available on the EMA website, which can be commented on until 07 October 2025. These include Chapter 4, Annex 11 and Annex 22.

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In April 2025, the WHO published the new guideline ‘TRS 1060 - Annex 2: WHO good practice considerations for the prevention and control of nitrosamines in pharmaceutical products’ on its website, which must be taken into account by manufacturers and packagers of excipients, active ingredients, processing aids and finished medicinal products. It should be noted that WHO Annex 2 is to be regarded as a supplement to the existing GMP guidelines and their requirements with regard to nitrosamines, as set out, for example, in ICH M7 (R2).

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In July, the U.S. FDA (U.S. Food and Drug Administration) published an announcement on its website regarding the publication of a large number of so-called "Complete Response Letters (CRLs)". It is already mentioned that further CRLs are to follow in the future.

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