Last Updated on October 6, 2024 by The Health Master
Lupin, on July 12 has informed that United States Food and Drug Administration (USFDA) inspected its Nagpur Oral Solid Dosage facility from July 3 to July 11, 2023.
The inspection closed with issuance of a Form 483 with two observations.
“We are confident of addressing the observations raised, and will work with the USFDA to resolve them at the earliest,” Lupin said.
“We uphold quality and compliance issues with utmost importance and remain committed to be compliant with CGMP quality standards across all our facilities,” the company added.
On July 11, the company received the establishment inspection report (EIR) from USFDA for its Pithampur Unit-2 manufacturing facility that manufactures oral solids and ophthalmic dosage forms.
The EIR was issued post the last inspection of the facility conducted from March 21 to March 29, 2023.
The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).
USFDA completes inspection of Granules India in two facilities
USFDA completes inspection at Ajanta Pharma with zero observations: Gujarat
USFDA concludes inspection at Zydus with zero observation
USFDA completes inspection of Dr Reddy’s with zero observation
USFDA issues Form 483 with 11 observations IPCA Labs: Ratlam
USFDA issues Form 483 with 4 observations to Aurobindo Pharma
USFDA issues EIR to Lupin for Pithampur unit-2
USFDA gives nod for Sevelamer HCL tablets
Govt to establish recruitment Rules for Medical Device Officers
DCGI gives approval for Dupilumab to treat Atopic Dermatitis
Stringent action to be taken against companies that make spurious drugs: HM
USP establishes Program Unit Team on testing of Excipients
Major fire breaks out at Govt’s medicine godown: Odisha
CDSCO to streamline Drug Regulations for Quality and Patient Safety
Pharma Cleanrooms: Ensuring compliance with GMP
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
