Last Updated on October 15, 2024 by The Health Master
The US Food and Drug Administration (USFDA) has issued a warning letter to Sun Pharmaceutical Limited about manufacturing errors at its Gujarat-based plant, including failing to follow the necessary documented procedures intended to avoid microbiological contamination of drug goods.
From April 26 to May 9, 2022, the manufacturing facility was under inspection by the health authority.
The Halol plant, which creates finished pharmaceutical products, was found to have a number of violations, according to a warning letter from the USFDA.
“This warning letter summarizes substantial violations of Current Good Manufacturing Practice (CGMP) standards for finished pharmaceuticals,” the USFDA wrote in the warning letter.
In its other warning letter to the Mumbai-based company, the USFDA cited the drug company’s failure to establish and adhere to appropriate written procedures that are intended to prevent microbiological contamination of drug products that are claimed to be sterile, and that include validation of all aseptic and sterilisation processes.
Warning letter further states:
- Your drug goods are adulterated because your manufacturing, processing, packing, or holding processes, facilities, or controls don’t follow CGMP guidelines.
- Your firm failed to undertake activities within clearly defined zones of suitable size and to have separate or defined areas or such other control measures necessary to prevent contamination r mix-ups in aseptic processing facilities.
- Your ISO 5 cleanroom spaces used for aseptic compounding and filling were inadequately protected and poorly built.
- Sterile drug goods are exposed in the ISO 5 region, making them susceptible to contamination.
- Your firm failed to employ equipment that is of proper design, adequate size, and suitably positioned to facilitate operations for its intended use, as well as for its cleaning and maintenance.
- Significant findings in this letter demonstrate that your company does not operate an effective quality system in accordance with CGMP.
USFDA issues warning letter to Sun Pharma for Halol facility
USFDA issues warning letter to Glenmark’s Goa facility
USFDA issues warning letter to Lupin
USFDA issues warning letter to Lupin API plant
USFDA issues warning letter to Aurobindo Pharma for manufacturing lapses at API plant
USFDA gives warning letter to Aurobindo Pharma for API facility
Tramadol: 3 Pharmaceutical Companies under scanner
NMC allows foreign medical graduates to finish internship in India
NABL suspends accreditation of 80 laboratories
NPPA fixes Retail Price of 4 scheduled formulations: January 2023
Medical Oxygen plants to be put on digital map
JIPMER: Nursing Officer 2022 result declared, Download
Sale of coronary stents: High Court seeks stand of Centre and NPPA
List of approved FDCs (Fixed Dose Combinations) Updated
List of approved New Drugs Updated
Latest Notifications regarding Pharmaceutical
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
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: