ZERO 483 INSPECTIONAL OBSERVATIONS
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.
USFDA issues Form 483 with five observations to Torrent Pharma unit
Torrent Pharmaceuticals announced that the US Food and Drug Administration (USFDA) issued a Form 483 with five observations after inspecting its manufacturing plant in Indrad, Gujarat, from June 3 to June 12. The inspection included a pre-approval inspection (PAI) and a Good Manufacturing Practice (GMP) inspection. The company stated that there were no observations related to data integrity. Torrent Pharma plans to respond to the USFDA within the prescribed time frame and work closely with the agency to address the observations promptly.
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.
USFDA issues Form 483 with 1 inspectional observation to Cipla's Kurkumbh unit
A routine current Good Manufacturing Practices (cGMP) inspection was conducted by the USFDA at the company's manufacturing facility at Kurkumbh, Maharashtra from April 29, 2024, to May 8, 2024, Cipla said in a regulatory filing.
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.
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Aurobindo's Andhra plant receives 1 observation from USFDA after inspection
Aurobindo Pharma has received a Form 483 with one observation from the US FDA after an inspection of its formulation production facility in Andhra Pradesh. The observation is procedural in nature and the company intends to respond to the FDA and work to resolve the issue promptly. A Form 483 is issued when violations of relevant acts are observed during an inspection.
Biocon Biologics gets eight observations from USFDA for Malaysia insulin facility
The US drug regulator issued 6 observations for drug substance, drug product units and quality Control laboratories and 2 observations for the delivery devices unit of Biocon Sdn Bhd, Malaysia, a subsidiary of Biocon Biologics.
USFDA issues Form-483 with two observations for Lupin's Nagpur plant
Lupin's Nagpur facility has received two observations from the USFDA through Form-483 due to violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The company assured that it would resolve the issues raised and is confident of doing so soon. The USFDA conducted an inspection of the facility from July 3-11, 2023.
Gland Pharma's Hyderabad unit gets one observation from USFDA after inspection
"This observation is procedural in nature and the corrective and preventive actions for this observation will be submitted to the USFDA within the stipulated period," Gland Pharma stated. The observation issued is neither a repeated observation nor related to data integrity, it added.
Dr Reddy's clears USFDA inspection for two plants
Dr Reddy's said it has received establishment inspection report (EIR) for its formulations manufacturing unit in Srikakulam (FTO SEZ PU2), Andhra Pradesh. EIR means closure of inspection. The inspection was conducted from June 12, 2023 to June 16, 2023.
Ipca Labs falls 3% after USFDA issues Form 483 to API unit
Shares of Indian pharmaceutical company, Ipca Laboratories, fell by 3% after the US Food and Drug Administration (USFDA) issued a Form 483 report, citing 11 observations of its API manufacturing facility situated in Ratlam. Form 483 is issued when an inspector has found conditions that could violate FDA regulations. Ipca said it takes quality and compliance issues seriously and will submit a response in the prescribed time. Trendlyne data showed that the stock's day RSI (14) is at 57.8, while the MACD is above its center and signal line, which is a bullish indicator.
Alembic Pharmaceuticals receives 2 observations for Gujarat facility from USFDA
As per US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Cipla's Pithampur unit gets 8 observations from USFDA after inspection
The US Food and Drug Administration (USFDA) conducted a current Good Manufacturing Practices (cGMP) inspection at the manufacturing facility from February 6 - 17, the Mumbai-based drug firm said in a regulatory filing. On conclusion of the inspection, the company has received 8 inspectional observations in Form 483, it added.
USFDA issues Form-483 with 8 observations to Lupin's drug, API production facilities in Mandideep plant
The USFDA had inspected the Mandideep Unit-1 facility in Madhya Pradesh from November 14, 2022, to November 23, 2022, the Mumbai-based drug maker said in a regulatory filing. "The inspection of the facility closed with issuance of a Form-483 with eight observations each for the drug product facility and active pharmaceutical ingredient (API) facility at the site," it added.
Bajaj Healthcare jumps 8% after USFDA inspection of Vadodara API plant
Bajaj Healthcare is a leading manufacturer of APIs, Intermediates and Formulations established in the year 1993. It specializes in manufacturing intermediates, API, formulations & Nutraceuticals. BHL has a strong presence globally in countries like Europe, the US, Australia, Africa, Middle East and South America.
USFDA issues Form-483 with 3 observations to Alkem Lab's St Louis plant
"There is no data integrity observation. This pre-Approval Inspection is part of the routine business operations and the company shall submit to US FDA within the stipulated timeline, a detailed response to close out the said observations," the company said.
Biocon drops 4% as USFDA issues form 483 for 3 sites
As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Aurobindo Pharma drops 3% as USFDA issues 'Form 483' to US arm unit
At the end of the inspection, Aurolife has been issued a 'Form 483' with one observation and the observation is procedural in nature and there are no data integrity issues. We will respond to the USFDA within the stipulated timeline and work closely with the USFDA to address the observation at the earliest," the company said in a regulatory filing.
US FDA issues Form 483 with 10 observations to Sun Pharma’s Halol unit
Listed pharmaceutical entity Sun Pharmaceutical Industries on Tuesday informed the exchanges that the US FDA has issued Form 483 with ten observations to the company’s Halol unit.
Windlas Biotech rallies 19% on concluding EU inspection with zero critical observation
The recently listed pharmaceuticals player said it has concluded European Union's good manufacturing practice inspection carried out by the National Institute of Pharmacy and Nutrition, Hungary, for its Plant-IV at Dehradun with zero critical observations.
Understanding US FDA inspection: How investors and management can avoid heartburn
With India playing a significant role in the global pharmaceutical sector, one may wonder about the quality control practices adopted in the country while supplying drugs to much-developed economies such as the US & UK. USFDA inspections shed some light on this.
USFDA issues six observations after inspection of Biocon's Malaysian arm manufacturing facility
A Biocon spokesperson said the company is confident of addressing these observations through procedural enhancements and an appropriate Corrective and Preventive Action Plan (CAPA), which will be submitted to the USFDA in the stipulated time.
Alkem Laboratories says USFDA inspection at Taloja facility ends with 'zero' observations
The US Food and Drug Administration (USFDA) had conducted a remote and virtual bio-analytical inspection of the company's Bioequivalence Center located at Taloja, Maharashtra from July 26-28, 2021, Alkem Laboratories said in a regulatory filing.
Alembic Pharma gets five observations from USFDA for Gujarat facility
As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when an investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
USFDA issues Form 483 with 5 observations to Biocon's Bengaluru facility
As per the USFDA, a Form 483 is issued to Biocon's management at the conclusion of an inspection when investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic Act and related Acts. At the conclusion of the inspection of the Bengaluru facility, USFDA issued a Form 483, with 5 observations.
Biocon Bengaluru unit pre-approval inspection by USFDA concludes with zero observations
Biocon on Monday said that pre-approval inspection of the Bengaluru facility of its arm conducted by US health regulator was concluded with zero observations.
Indoco Remedies receives EIR from USFDA
Indoco Remedies got "establishment inspection report (EIR) for its Clinical Research Organisation, AnaCipher, located at Hyderabad for the inspection carried out by the United States Food and Drug Administration (division of New Drug Bioequivalence Evaluation) from August 5 to August 9, 2019," the filing said.
USFDA concludes inspection of Unichem Lab's Roha facility
The inspection was a post-approval inspection and successfully concluded.
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