Last Updated on December 31, 2023 by The Health Master
The U.S. drug regulator has flagged three procedural lapses in a pre-approval inspection at Zydus Lifesciences Ltd.’s manufacturing facility SEZ-1, located in Ahmedabad.
“The U.S. Food and Drug Administration (USFDA) conducted an inspection at the manufacturing facility SEZ-1 of Zydus Lifesciences Ltd., located at Pharmez, Ahmedabad, from March 20 to 24, 2023,” the company had said in a March 30 exchange filing.”
“The inspection was a pre-approval inspection as well as a good manufacturing practices audit and concluded with three observations.”
This will involve the issuance of a Form 483, which is issued when investigators have observed any condition that, in their judgement, may constitute a violation of the Food, Drug, and Cosmetic Act and related acts.
“There were no data integrity-related observations,” the company said. Zydus Lifesciences is addressing these observations and will respond to them within the stipulated time, the company said.
BQ Prime has obtained a copy of the three observations from the USFDA.
These are:
- Equipment and utensils are not cleaned and maintained at appropriate levels to prevent contamination that would alter the safety and quality of the drug product. Specifically, the cleaning of manufacturing equipment and its verification for cleanliness are inadequate.
- Failure to review an unexplained discrepancy, whether or not the batch has been distributed. Three inadequate investigation incidents were noted.
- Laboratory controls do not include the establishment of appropriate test procedures to ensure products conform to certain standards. In particular, the quality unit lacked adequate oversight on the use of qualified reference standards in the validation of analytical methods and testing of drug products filed in U.S. markets. Five instances were observed.
Zydus Lifesciences has yet to respond to BQ Prime’s emailed queries on the implications of the observations and the impact on the pending approvals and launch timelines.
It’s also yet to comment on the steps being taken to address these issues and the expected timelines for resolution.
USFDA issues Form 483 with zero observation to Piramal
USFDA issues Form 483 with 10 observations to Lupin, Pithampur
USFDA issues Form 483 with 2 observations to Alembic, Gujarat
USFDA issues Form 483 with 3 observations to Bliss GVS Pharma, Maharashtra
USFDA issues Form 483 with one observation to Torrent, Gujarat
USFDA issues Form 483 with 4 observations to Indoco Remedies, Goa
Govt allows NIB to conduct more tests on Medical Devices
USFDA gives approval for next generation Pneumococcal Vaccine
USFDA gives approval for this ALS drug
Relabeling of drug prices based on recent price changes in NLEM products
Drug recall: Thyronorm tablets recalled due to this reason
Govt likely to announce National Medical Device Policy
Drug alert: 48 out of 1497 samples declared as NSQ in March 2023
Wet Granulation vs Dry Granulation: Understanding the Key Differences
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:
