FDA INSPECTED MANUFACTURING SITES
South Korean firm HyVision System inks deal with Karnataka to build plant near Foxconn facility in Bengaluru
South Korean HyVision System signed an agreement with Karnataka on Friday to allow the company to build a factory for camera inspection machines. This unit will be near the Foxconn facility, which is close to Bengaluru's Kempegowda International Airport in Devanahalli.
Warning letter: USFDA pulls up Sun Pharma for manufacturing issues at Dadra facility
"Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitise and/or sterilise equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements," the USFDA said.
US lawmakers questions FDAs drug inspection programme in India and China
Three top American lawmakers have raised concerns about the FDA's foreign drug inspection program in India and China. In a letter to FDA Commissioner Robert Califf, they highlighted inconsistencies in inspection outcomes from January 2014 to April 2024. Some inspectors reported no compliance issues in numerous inspections, while others found issues in almost every inspection. The lawmakers, Cathy McMorris Rodgers, Brett Guthrie, and Morgan Griffith, pointed out these discrepancies and called for an investigation into the skill and thoroughness of FDA inspectors to ensure rigorous and consistent inspections.
Biocon gets 4 observations from USFDA for Andhra Pradesh facility
Biocon received four observations from the US health regulator after a GMP inspection at its API facility in Andhra Pradesh.
Boeing may have installed many faulty parts on new 737 Max planes, whistleblower alleges
A Boeing quality inspector alleges that the company mishandled and lost track of hundreds of faulty parts, some possibly installed on new 737 Max planes. Whistleblower claims detailed in a complaint to OSHA were made public by a Senate subcommittee. Boeing is reviewing the claims amid ongoing scrutiny over safety and quality practices.
View: India's pharma giants set sights on superior quality standards
India, known as the 'pharmacy of the world,' ranks third in global drug production and supplies vaccines to over 200 countries. With a target to reach $120-130 billion by 2030, maintaining high quality is crucial. Focus areas include robust investigations, skilled workforce development, and embedding quality in product development. India faces increased scrutiny from global regulators, necessitating adherence to stringent quality standards. Recent moves by CDSCO aim to streamline drug export licensing. Upholding quality is key for India's pharmaceutical industry to remain a reliable global supplier.
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Don't see any material changes in policies going ahead: Rajeev Thakkar
And if we step back what does the election outcome mean for the markets? So, barring the pre-election and post-election for a week, 10 days, people will move on.
Stocks in news: Godrej Properties, Whirlpool, Solara Active Pharma, TCS, Nestle India
Bandhan Bank reported a net profit of Rs 54.62 crore for the quarter ended March 2024, which was down from Rs 808 crore in the year ago period.
US FDA inspects Vishakhapatnam facility of Solara Active Pharma
The US Food and Drug Administration (FDA) completes inspection of Solara Active Pharma Sciences' API manufacturing facility in Visakhapatnam, Andhra Pradesh, with no observations. Solara confirms compliance with FDA standards. The facility, dedicated to Ibuprofen API production, marks Solara's second successful FDA inspection. The company aims for global market expansion with FDA-approved facilities.
Why contaminated foods can easily enter your kitchen
Though India has a food regulator, the actions regulators abroad take on exported foods seem to get wider attention. There is a danger of trust deficit that needs urgent attention through better testing, penalties, and transparency.
USFDA pulls up Natco Pharma for manufacturing lapses at Telangana plant
Natco Pharma's Telangana plant violated cleanliness and sterilisation standards at Kothur Village facility per USFDA. The warning letter mentioned cross-contamination, inadequate cleaning procedures, and the need for comprehensive investigations and corrective actions.
Jubilant gets VAI classification from USFDA for Roorkee unit
As per the USFDA, a VAI inspection classification indicates that although investigators found and documented objectionable conditions during the inspection, FDA will not take or recommend regulatory or enforcement action because the objectionable conditions do not meet the threshold for action at this time.
USFDA issues warning letter to Kilitch Healthcare for Navi-Mumbai plant
The US Food and Drug Administration (USFDA) has issued a warning letter to Kilitch Healthcare India for manufacturing lapses at its plant in Maharashtra. The letter highlights various violations of current good manufacturing practice (CGMP) regulations, including packing drugs in insanitary conditions and failing to establish proper procedures to prevent contamination. The USFDA observed that the facility was poorly cleaned and maintained, posing risks of contamination. Kilitch Healthcare has committed to suspending production of all drugs for the US market. The company must address the violations and provide a plan for corrective action.
Taiwan earthquake likely to have minimal impact on global electronics supply chain, Indian market remains stable
The 7.4 magnitude earthquake in Taiwan, which caused widespread disruption in chip fabrication plants, is likely to have minimal impact on the global value chain in electronics manufacturing, including India. Industry executives and market trackers do not expect any adverse impact on prices or supply chains of mobile phones and other electronics items in India, which heavily relies on the Southeast Asian island nation for components.
US FDA to boost inspections of drug manufacturing units in India
The FDA plans to increase inspections at Indian drug manufacturing units in 2024. They conducted over 200 inspections in 2023. The Indian pharmaceuticals industry needs to implement good manufacturing practices. Government investment in automation, the drug regulatory body, and drug quality monitoring is necessary.
Yogi Adityanath to inaugurate Defence Corridor in UP on Feb 26
Chief Minister Yogi Adityanath is slated to inaugurate the Defence Corridor in Uttar Pradesh, featuring the nearly completed Small Calibre Ammunition Manufacturing Plant by the Adani Group. The administration is actively preparing for the event, including the construction of a helipad and a storehouse within the corridor. Uttar Pradesh, a key player in India's economy, boasts a massive population and holds top positions in labor force availability, manufacturing, MSMEs, and EODB rankings. The Uttar Pradesh Defence Industrial Corridor aims to bolster India's Aerospace and Defence sectors, reducing dependence on foreign imports.
Skydio plans to bring commercial drones to India following defence tie-up
Skydio, an American drone manufacturer, plans to introduce its commercial drones in India following a recent tie-up with an Indian company to produce unmanned aerial vehicles (UAVs) for defence customers in the Indo-Pacific region. While the company initially focuses on defence products in new markets, it aims to expand into non-military and non-government sectors over time. Skydio's collaboration with Aeroarc will develop small uncrewed aircraft systems (SUAS) for the Indian defence ministry and other global defence customers, showcasing its commitment to advancing drone technology in India.
FAA says 94% of Boeing 737 MAX 9 planes inspected, back in service
The FAA lifted its grounding of MAX 9 airplanes on Jan. 24 after it halted flights following the cabin panel blowout on an Alaska Airlines jet on Jan. 5. The FAA said 78 of 79 United Airlines MAX 9 planes have been inspected and returned to service and 57 of 65 Alaska MAX 9 planes.
How India Inc is boosting productivity by using intelligent technologies
Leading manufacturers in India are digitizing factories to adopt the smart shop floor concept and boost productivity. Companies like Larsen & Toubro, RPG Group, MG India, Hyundai, and Hindustan Zinc are investing in digital technologies such as IoT, AI/ML, image analytics, blockchain, and advanced automation. RPG Group increased its digital investment and saw benefits in process scrap reduction, machine uptime increase, and lower maintenance and energy costs.
Alaska Airlines cancels flights on certain Boeing planes through Saturday for mandatory inspections
Alaska Airlines cancels Boeing 737 Max 9 flights after in-flight fuselage blowout. The grounding, prompted by a door plug incident, affects 110-150 daily flights. United Airlines, the only other US Max 9 operator, cancels 167 flights. FAA orders Boeing to revise inspection guidelines after Alaska and United find loose bolts and other issues. Boeing CEO acknowledges a "quality escape" and updates procedures. Kayak reports a three-fold increase in users filtering aircraft type after the incident. Boeing's Max, troubled since 2018 crashes, faces renewed safety concerns and public scrutiny.
USFDA issues Form 483 with 5 procedural observations to Torrent Pharma's Gujarat unit
Torrent Pharmaceuticals said Tuesday that the US health regulator has given them a Form 483 with five procedural comments after inspecting their oral manufacturing facility in Gujarat, India. According to the US Food and Drug Administration (USFDA), Form 483 is given to a company's management after an inspection if the investigator notices any conditions that might break the rules under the Food Drug and Cosmetic (FD&C) Act and related Acts.
USFDA pulls up Intas Pharma for manufacturing lapses at Ahmedabad plant
In a warning letter to the company's CEO and MD Nimish Chudgar, the US Food and Drug Administration (USFDA) has pointed out various manufacturing lapses at the Matoda-Sanand, Ahmedabad-based facility.
Fruit recall: Listeria risk in peaches, plums, nectarines - learn more about the disease
FDA has recalled peaches, plums, and nectarines sold between May and November '22-'23 due to listeria risk. CDC reports 11 illnesses, 1 death. If symptoms like fever or nausea occur, seek medical help. Dispose of affected products and stay informed for your health.
USFDA pulls up Cipla for manufacturing lapses at Pithampur plant
A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. "Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed," the USFDA stated in the letter.
Desi pharma pangs continue for India despite dose to fortify pharmacy of the world tag
India, once the 'pharmacy of the world', is struggling to establish itself as an elite player due to poor manufacturing practices that have led to deaths in some parts of the world, including children. The deaths of children in Gambia in 2022 and the deaths of 65 children in Uzbekistan last year have highlighted the lapse in the quality of drug production in certain India-based pharmaceuticals.
Indian eyedrop maker issues recall of various eye drops in US for potential safety reasons
Kilitch Healthcare India Limited has recalled 27 types of eye drops sold in the U.S. due to safety concerns arising from insanitary conditions found by FDA investigators. The FDA had previously warned consumers about eyedrops from major retailers without disclosing Kilitch as the manufacturer.
FDA warns consumers of infection risk in over-the-counter eyedrops
The FDA warns against using over two dozen over-the-counter eyedrops due to infection risk, potentially leading to blindness. This advisory includes lubricating drops from six companies, like CVS Health and Target, and urges consumers to stop using them. The FDA requested recalls due to unsanitary conditions in the production facility, though its location remains undisclosed. No injuries were reported, but the FDA encourages reporting.
Biocon Biologics' Malaysia insulin facility classified by US FDA for official action
Biocon Biologics has announced that its insulin manufacturing facility in Johor, Malaysia has been classified as an official action indicated (OAI) by the US Food and Drug Administration (FDA). This status may result in delays or withholding of pending product approvals from the facility. The company has submitted a corrective and preventive action (CAPA) plan
Torrent Pharma says US FDA issues 'EIR' for company's manufacturing facility
Torrent Pharmaceuticals on Thursday said that the US Food and Drug Administration (US FDA) has issued an Establishment Inspection Report (“EIR”) for the company's manufacturing facility at Dahej, Gujarat. EIR means closure of inspection.
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