GMP News - Inspections/Audits

23.11.22

Broader Acceptance of GMP Inspection Reports from PIC/S Countries

Some authorities within the PIC/S want to mutually recognise GMP inspection reports in order to avoid duplication of work. There is now a corresponding statement on this.

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23.11.22

FDA Warning Letter to Drug Manufacturer in Puerto Rico

Just recently, we reported on a Warning Letter to an American manufacturer of hand sanitizer drug products. Now another Warning Letter has been published by the U.S. Food and Drug Administration (FDA), also addressed to such products. In this case, it is about a drug manufacturer located in Puerto Rico. In addition to formal GMP violations and inadequate analytical testing, the FDA also criticizes the overall condition of the production facility.

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16.11.22

MHRA resumes international Inspections

In a blog post, the UK MHRA comments on the resumption of international GMP inspections and the validity of expired GMP certificates.

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16.11.22

FDA Warning Letters of the Fiscal Year 2022: the "Top Ten" GMP Deficiencies

The analysis of the Warning Letters sent out in fiscal year 2022 offers a revealing overview of what FDA inspectors find when they visit the production facilities of medicinal product manufacturers. Read more about the "Top Ten" GMP violations.

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16.11.22

FDA Warning Letter again Highlights the Importance of Analytical Testing for Hand Sanitizers Manufacturers

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a U.S. manufacturer. Therein, the FDA once again highlights the importance of analytical testing of incoming raw materials, finished drug product testing and stability testing. In the case in question, a manufacturer of OTC drug products had been found to have significant deficiencies in these areas.

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16.11.22

FDA criticises Root Cause Analysis and CAPA in a Warning Letter

In a Warning Letter to a US manufacturer, the FDA criticises investigations after deviations in the media fill. Also, derived CAPA measures did not go far enough for the FDA.

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15.11.22

FDA sends Warning Letters to Amazon and Walmart

The U.S. Food and Drug Administration (FDA) has issued Warning Letters to Amazon and Walmart. Laboratory analyses showed that both companies sold products that contained diclofenac, which was not listed on the product labels. The FDA sees this as a potential health risk for consumers.

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02.11.22

FDA Warning Letter for Chinese OTC Hand Sanitizer Drug Products Manufacturer

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Chinese manufacturer. The FDA blames the company in question for a whole series of GMP violations, including to identity testing, cleaning and maintenance of equipment, microbial testing and QU oversight.

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02.11.22

Cross Contamination Risk: Production stopped

In April, the US FDA inspected a manufacturer of OTC products in Mexico. Due to the deficiencies found, in particular the unacceptable risk of contamination, the production was stopped.

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02.11.22

Sterile Product Manufacturing Process: Warning Letter to Texas Longhorn

After incomplete processing of defects listed in a 483, the Austin-based compounding manufacturer Texas Longhorn received a Warning Letter from the FDA.

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26.10.22

FDA: New Inspection Guidance

The US Food and Drug Administration (FDA) has updated two Compliance Program Guides (CPGs) on GMP inspections. One for pre-approval inspections (PAI) and one for routine surveillance inspections.

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19.10.22

How to get free Access to FDA 483s

FDA's Office of Regulatory Affairs (ORA) publishes electronic copies of various inspection and related records on their websites.

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19.10.22

FDA Warning Letter: Product Mix-Ups and Insanitary Conditions at US Repackager

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a drug manufacturing facility in Missouri. The company failed to adequately investigate the presence of foreign tablets in the drug products. Furthermore, during an FDA inspection, one operator was observed to pick individual tablets up off of the floor and place them directly into the feed hopper.

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19.10.22

How to react to Deficiencies after an FDA Inspection?

GMP deficiencies are often identified during FDA inspections. Responding to an FDA deficiency report is important, otherwise a Warning Letter may be issued. But how should one respond?

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21.09.22

FDA Warning Letter: Potentially Carcinogenic Contaminants in Hand Sanitizers

The U.S. Food and Drug Administration (FDA) has again found genotoxic and potentially carcinogenic impurities in hand sanitizers. In this case, it is about an American manufacturer in whose products benzene, acetaldehyde and acetal impurities were detected at unacceptable levels.

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