USFDA FORM 483
USFDA issues Form 483 with 8 observations to Aurobindo's Telangana unit
Aurobindo Pharma faces scrutiny. The US FDA inspected its Bachupally, Telangana plant. The inspection occurred between August 25 and September 5. Following the inspection, the US FDA issued a Form 483. The form contained eight observations. Aurobindo Pharma stated the observations are procedural. The company plans to respond to the US FDA within the given timeframe.
Dr Reddy's gets seven observations from USFDA for Andhra plant
Dr Reddy's Laboratories faces scrutiny. The USFDA issued a Form 483 after inspecting their Srikakulam facility. The inspection, which occurred in July 2025, revealed seven observations. These observations relate to potential violations of the Food, Drug and Cosmetic Act. Dr Reddy's plans to address these concerns promptly. The company aims to resolve the issues within the given timeframe.
USFDA issues Form 483 with 7 observations to Natco's pharma Hyderabad division
Natco Pharma announced that its Hyderabad-based pharma division received a Form 483 with seven observations from the USFDA following an inspection conducted in June 2025. The company is confident in addressing these observations within the given timeframe. Natco Pharma remains dedicated to adhering to cGMP standards and delivering high-quality products to its global customer base.
Glenmark gets five observations from USFDA for Monroe plant
Glenmark Pharmaceuticals announced that its Monroe, North Carolina manufacturing plant received a Form 483 with five observations from the USFDA following a GMP inspection conducted in June 2025. The company stated that the observations are procedural and don't involve data integrity issues. Glenmark is committed to addressing the concerns and will respond to the USFDA within the required timeframe.
Sun Pharma gets eight observations from USFDA for Halol plant
Sun Pharma announced that the USFDA issued a Form 483 with eight observations after inspecting its Halol manufacturing plant in Gujarat. The USFDA conducted a Good Manufacturing Practices (GMP) inspection at the facility from June 2-13, 2025. The Form 483, issued at the inspection's conclusion, highlights conditions that may violate the Food, Drug, and Cosmetic Act and related regulations.
Dr Reddy's gets 2 observations from USFDA for Telangana API plant
Dr. Reddy's Laboratories received a Form 483 with two observations following a GMP inspection by the USFDA at its API manufacturing plant (CTO-5) in Miryalaguda, Telangana. The inspection, conducted from May 19 to May 24, 2025, identified potential violations of the Food Drug and Cosmetic Act. The company plans to address the concerns within the given timeframe.
- Go To Page 1
USFDA issues Form 483 with 11 observations to Raleigh plant of Aurobindo Pharma arm
Aurobindo Pharma Ltd announced that the USFDA issued a Form 483 with 11 observations following an inspection of its Aurolife Pharma LLC's Raleigh plant in North Carolina. The company stated that the observations are procedural and it will respond with corrective actions. Aurobindo Pharma anticipates no significant impact on its operations or supplies from the facility.
USFDA issues Form 483 with 3 three observations to Gland Pharma's Visakhapatnam unit
Gland Pharma Ltd's facility at Visakhapatnam received three Form 483 observations from the USFDA after a recent inspection for sterile APIs. The company stated that these observations are procedural and not related to data integrity. Corrective actions will be submitted to the USFDA within the given timeframe.
Cipla shares in focus after Goa facility receives form 483 with one observation from USFDA
Cipla share price has risen by 10% over the past 12 months and 64% over the last three years. The company's current market capitalization is Rs 1,16,772 crore. The consensus recommendation from 37 analysts for the stock is a 'Buy'.
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.
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 Laboratories launches Regadenoson injection in US market
The injection is a pharmacologic stress agent for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. In a separate filing, Dr Reddy's said it has issued a Form 483 with one observation by the USFDA after a routine GMP inspection at its API manufacturing facility (CTO 1) in Bollaram, Hyderabad.
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.
Dr Reddy's Laboratories says its Andhra plant gets two observations from USFDA
The US Food and Drug Administration (USFDA) completed a pre-approval inspection at the company's formulations manufacturing facility FTO 11 in Srikakulam, Andhra Pradesh on Thursday, Dr Reddy's said in a regulatory filing. The inspection was conducted from June 30, 2022 to July 7, 2022.
Dr Reddy's gets 3 observations from USFDA for US-based API plant
The audit of the company's active pharmaceutical ingredients (API) manufacturing plant at Middleburg, New York has been completed by the US Food and Drug Administration (USFDA), the Hyderabad-based drug major said in a regulatory filing.
Alembic Pharma receives 4 observations from USFDA for Panelav facility
"The US Food and Drug Administration (USFDA) has conducted an inspection at Alembic Pharmaceuticals general oral solid formulation facility located at Panelav from 9-13 March, 2020," the drug firm said in a filing to the BSE. This was a scheduled inspection, and at the end of the inspection, the USFDA issued a Form 483 with four procedural observations.
USFDA concludes inspection of Unichem Lab's Roha facility
The inspection was a post-approval inspection and successfully concluded.
USFDA issues 5 observations to Dr Reddy's plant in Hyderabad
Dr.Reddy's Laboratories was issued a Form 483 which notifies the company's management of objectionable conditions, with 5 observations.
USFDA completes Biocon's Telangana plant inspection
The inspection was concluded without any observations and no Form 483 was issued, the company said.
USFDA completes inspection at Caplin Point Lab's sterile injectable facility in Tamil Nadu
"The United States Food and Drug Administration (USFDA) has conducted an inspection at our sterile injectable site (CP-IV) located at Gummudipoondi from August 30 to September 06, 2018," Caplin Point Laboratories said in a BSE filing.
Biocon gets 6 observations from USFDA for Malaysia facility
As per the US health regulator, observations are made in Form 483 when investigators feel that conditions or practices in the facility are such that products may become adulterated or render injuries to health.
Received observations from USFDA, responded to all: Biocon
The company was responding to reports that the US health regulator has issued observations under Form 483 highlighting issues related to quality control tests.
Lupin gets three observations from USFDA for Goa plant
As per the USFDA, observations are made in Form 483 when investigators feel that practices in the facility are such that products may become adulterated.
USFDA made 9 observations post Halol unit inspection: Sun Pharma
The United States Food and Drug Administration (USFDA) inspected the Halol facility from November 17, 2016 through December 1, 2016, Sun Pharma said in a BSE filing.
FDA issues observations post Sun Pharma Halol plant inspection
The approval of several of Sun's key drugs in the United States, the drugmaker's biggest market, depends on the clearance on its Halol plant in Gujarat.
Load More
