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In a recent Warning Letter, the FDA outlines severe GMP deficiencies in the manufacture of OTC hand sanitizers and antibacterial soaps, including missing identity testing, lack of stability data, and absent process validation. Critical raw materials such as glycerin and ethanol were accepted without proper testing – despite their known risk of contamination with diethylene glycol (DEG), ethylene glycol (EG), or methanol, substances that have caused fatal poisoning incidents worldwide.

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Back in October/November 2024, the FDA carried out an inspection at a US manufacturer of OTC products and uncovered a number of GMP deficiencies, including in process validation, which has now led to a warning letter. Continue reading.

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The Investigations Operations Manual (IOM) is the primary operational reference for FDA investigators. Although primarily used internally by FDA staff, it is available publicly. The Manual has now been revised.

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The US FDA inspected an Indian API manufacturer from 4 to 12 September 2024 and found serious GMP violations. The deficiencies relate in particular to inadequate cleaning procedures and the associated risk of contamination, inadequate handling of quality deficiencies and violations of data integrity.

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In a previous News we reported on deficiencies in media fills. The topic is a priority for the FDA! In a recent Warning Letter, media fills were criticised again, as well as deficiencies in smoke studies. What did the FDA criticise?

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The European Medicines Agency (EMA) has published a Q&A document on how third-party audits should be reflected in Part C of the QP Declaration.

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In a recent Warning Letter, the FDA criticised the lack of Media Fills. What does the FDA expect from Media Fills?

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The US FDA inspected an Indian pharmaceutical manufacturer from 26 August to 6 September 2024 and found serious GMP violations. The deficiencies relate in particular to the cleaning and maintenance of production equipment, the structural condition of the facility and data integrity. Read more.

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The U.S. Food and Drug Administration (FDA) has issued a new Warning Letter following an inspection that uncovered serious GMP deficiencies in the manufacturing of an OTC drug product, including missing release testing, lack of stability data, and inadequate quality oversight.

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During an inspection, the US FDA found significant violations in the area of data integrity and documentation at a manufacturer of OTC drugs in Thailand. The violations identified relate to incomplete laboratory data, manipulated records and inadequate control of electronic systems.

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