GMP News - Inspections/Audits

19.04.23

FDA Warning Letter: Inadequate API testing

In March 2023, the U.S. FDA issued a Warning Letter to the US American company "Omega Packaging Corp" after having inspected its site in October and November 2022.

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19.04.23

FDA Warning Letter to Indian Manufacturer: Glycerine used in Manufacturing not Tested according to USP

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to an Indian company, registered as a manufacturer of OTC and homeopathic drug products. Some of the formulations contain high percentages of glycerin, but this high-risk component was not adequately tested according to the USP requirements. Thus, it was not ensured that the relevant safety limits for the levels of diethylene glycol or ethylene glycol were met.

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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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05.04.23

Laboratory Data Integrity issues once again caused a Warning Letter

In February 2023, the U.S. FDA issued a Warning Letter (WL) to the US American company "Dunagin Pharmaceuticals Inc. dba Massco Dental" after having inspected its site in Arkansas in August/September 2022.

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28.03.23

GDP in the US: New FDA Guidance for Industry on Definitions of Suspect Product and Illegitimate Product

The U.S. Food and Drug Administration (FDA) has published a new guidance entitled "Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act". The document clarifies the agency's interpretation of specific terms used in the definitions of "suspect product" and "illegitimate product". It is primarily intended to assist trading partners in meeting verification obligations.

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28.03.23

FDA Warning Letter: Lack of Temperature and Humidity Control

The U.S. Food and Drug Administration (FDA) has published a Warning Letter sent to a drug manufacturer in Massachusetts, USA. Since the deficiencies found even concern simple GMP basic requirements, the company had to stop production and distribution in the meantime. What is actually interesting is that the FDA, among other things, explicitly criticizes the lack of a humidity control in the warehouse.

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28.03.23

Two New PIC/S GDP Guidance Documents Published

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has published two guidance documents for GDP inspectors, an Aide-Memoire on GDP inspections and a Q&A document. Both documents entered into force on 01 February 2023.

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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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15.03.23

Another FDA Warning Letter to US Manufacturer of Hand Sanitizers

The U.S. Food and Drug Administration (FDA) has once again published a Warning Letter to a US manufacturer of hand sanitizers. During an inspection, several CGMP violations were found. In addition to inadequate release testing in general, the finished products are likely to be contaminated with methanol.

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08.03.23

FDA Warning Letter to Turkish OTC Manufacturer

The U.S. Food and Drug Administration (FDA) sent a Warning Letter to a drug manufacturer in Istanbul. During an inspection, several CGMP violations were found. Among other things, this concerns identity testing of incoming components, process validation and stability testing.

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01.03.23

Entry in EudraGMDP means Production Stop for a Slovakian Company

A Slovakian company has its GMP certificate withdrawn after an inspection. The Qualified Person (QP) was also mentioned.

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21.02.23

GDP in the US: Consent Decree of Permanent Injunction against Importer and Distributor of APIs

A federal court has entered a consent decree of permanent injunction against a Florida-based drug importer and distributor. It prohibits the company from distributing active pharmaceutical ingredients (APIs) not manufactured, processed, or held in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). This was preceded by a legal dispute with the U.S. Food and Drug Administration (FDA).

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15.02.23

Warning Letter and Recall of a homeopathic Medicine for Children

FDA sends warning letter to the manufacturer of a homeopathic honey product, among other things because of microbiological contamination with Bacillus spec. Due to the advertised use for children, there was a not insignificant risk..

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15.02.23

Deficiencies at Sterile Manufacturer

In May 2022, the US FDA inspected an Indian sterile manufacturer, revealing numerous deficiencies that have now led to a Warning Letter. Among other things, deficiencies in media fill, plant and cleanroom design, and environmental monitoring were cited.

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15.02.23

The new ICH Q9 Revision on Quality Risk Management becomes Effective as of 23 July 2023: A Detailed Analysis

In January you could read about the publication of the revised ICH Q9 guideline. What is new with regard to quality risk management (QRM)?

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