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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FDA Making Life Difficult For Indian Pharma Companies
Some industry experts believe the US regulatory system is using the FDA inspection process to combat Indian pharmaceutical competition in the US. Eight Indian pharmaceutical companies have recently received 483s for cGMP violations since the start of 2024. All eight of the Indian companies sell their drugs in the United States. The eight companies from […]
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FDA Sears China’s Hengrui In Recent 483
When the FDA comes to your cGMP drug manufacturing facility, it is best to cooperate with them. However, Jiangsu Hengrui Pharmaceuticals in China decided not to play along and it cost them. The May FDA 483 criticized Hengrui for a long list of cGMP and manufacturing errors, such as subpar contamination controls, inadequate cleaning protocols, […]
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FDA Gets Into The Weeds On HCT/P Rules In Warning Letter To Human Tissue Firm
In May 2024, CBER at FDA issued a warning letter to Akan Biosciences for unresolved FDA audit observations after several months of back and forth discussions between the agency and Akan. The FDA 483 highlighted several issues regarding 585 vials of a human tissue product. Also, the warning letter spent a lot of time covering […]
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Why FDA Will Have Difficulty Regulating Marijuana
The FDA does an admirable job overall of protecting the public from defective foods, drugs and devices. But the recent federal rescheduling of marijuana, which was confirmed by the president recently, will pose challenges to the FDA. The idea is to move cannabis from Schedule I, which features drugs without an accepted medical use, such […]
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Zentalis Shares Drop 30% After FDA Puts Partial Hold on WEE1 Drug
FDA has put three trials of the WEE1 candidate by Zentalis on a partial hold after two deaths that are alleged to have been caused by sepsis. The deaths happened during the Phase 2 DENALI clinical study. The purpose of the study was to evaluate the synthetic lethal WEE1 inhibitor azenosertib in people with ovarian […]
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FDA Blasts Laurus Synthesis With Untitled Letter
This month, FDA, which delivered an FDA 483 to India’s Laurus Synthesis in January, followed up that regulatory rebuke with an untitled letter that detailed the company’s problems with its QC unit and improper equipment cleaning. An untitled letter deals with violations that do not rise to the level of a warning letter, but should […]
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FDA Warning Letter Delivered to Cue Health in May 2024
Cue Health recently slashed 49% of its staff, but the hits keep on coming for the medical device company. FDA sent Cue Health an FDA warning letter this month regarding the firm’s Emergency Use Authorized COVID-19 test. In a press release, FDA stated that it warns caregivers, healthcare providers, and home test users to not […]
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