India’s Zydus Hit With FDA Warning Letter
Zydus Lifesciences has been under intense FDA scrutiny in recent months, and received a warning letter for the Indian drugmaker’s production plant in Jarod in July 2024. Earlier in 2024, Zydus received two FDA 483s in a month after FDA inspections of two manufacturing sites in India. At that time, FDA stated the plants had […]
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FDA Finalizes cGMP Guidance for ANDA Facilities
In July, FDA outlined details on how it will assign a goal date according to a drug facility’s readiness for inspection. These rules include information for generic drug makers on how they can determine when drug plants associated with an application will be ready for an FDA audit in support of an ANDA or abbreviated […]
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EyePoint Receives FDA Warning Letter For cGMP Shortfalls Related To Eye Implant
Ophthalmology manufacturer EyePoint Pharmaceuticals received an FDA warning letter in July for its facility in Watertown, MA, according to the FDA website. EyePoint received an FDA 483 in February, which the company responded to in early March 2024. The FDA violations, which were found in the February audit, included poorly written procedures, batch discrepancies, and […]
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FDA Sends Warning Letter To Surgical Robot Maker Globus
FDA delivered a warning letter to Globus Medical in August 2024 for not following quality system regulations and medical device reporting requirements. The FDA warning letter also stated that the firm’s CAPA procedures were not properly addressed regarding quality problems, including Globus Medical’s analysis of reports of missing surgical screws. FDA sent the warning letter […]
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FDA Sends Warning Letters To Chinese Syringe Manufacturer
FDA sent warning letters Jiangsu Shenli and Jiangsu Caina in China in July 2024 regardings its practices in manufacturing plastic syringes. In April, the FDA also issued an import alert to both sites. FDA recently published the warning letters that show the agency conducted an FDA inspection of Jiangsu Shenli and Jiangsu Caina about the […]
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FDA Hits Aurobindo With OAI 483
FDA hit Indian drugmaker Aurobindo and its Eugia unit with an Official Action Indicated (OAI) 483 after a manufacturing plant inspection at the Bhiwadi facility in April 2024. OAI is the most serious of three FDA audit recommendations, and after the company announced the 483, it said that it is committed to partner with the […]
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FDA Reams Out Indian CDMO Brassica for Falsifying Data and Bad Hygiene
Indian CDMO was heavily criticized by FDA in a recent warning letter for falsifying data, doing aseptic processing with dirty and torn gowns, and more. The FDA warning letter to Brassica Pharma was essentially a not-to-do list when an FDA inspector comes for a visit. After the FDA inspected the firm’s Tarapur manufacturing facility in […]
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Most Common FDA 483 Violations in 2023
No one in the pharmaceutical or medical device industries relish receiving an FDA 483. However, if you get an FDA 483 with inspection observations, keep in mind that most citations are often overlapping, similar, or basically the same item applied to different parts of the business. For 2023, the most common FDA inspection observations are […]
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FDA Blasts Kilitch For Dirty Manufacturing Conditions
It is usually understood that drug company workers have to wear gowns and be gloved when handling drug products and APIs in clean rooms. It also is necessary that the workers wear shoes. However, Kilitch Healthcare India didn’t see things that way and failed to uphold such basic standards when FDA inspectors from the US […]
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Two Dr. Reddy’s Plants Hit With 483s in India
FDA recently handed 483s to two Dr. Reddy’s plants in India. After an FDA audit between May 30 and June 7, Dr. Reddy’s API facility in Pydibhimavaram, India was cited for four FDA 483 observations that were focused on the plant’s cGMP policies. FDA stated several OOS incidents didn’t have sufficient testing and follow-up after […]
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