INSUBCONTINENT EXCLUSIVE:
For around three months, there were multiple cross-contamination events at the facility, it said | Photo: X@ZydusUniverse3 min read Last
Updated : Sep 15 2024 | 11:58 AM IST
The US health regulator has pulled up Zydus Lifesciences for manufacturing lapses at its
Gujarat-based plant.
In a warning letter to company's Managing Director Sharvil Patel, the US Food and Drug Administration (USFDA) noted
that the drug maker failed to investigate contamination identified in drug products at its Jarod-based plant in Vadodara district.
The
USFDA said it inspected the manufacturing facility from April 15 to 23, 2024.
"This warning letter summarises significant violations of
current good manufacturing practice (CGMP) regulations for finished pharmaceuticals," it added.
It further said: "Because your methods,
facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated."A
on the manufacturing issues at the facility, USFDA noted: "Your firm failed to thoroughly investigate any unexplained discrepancy or failure
of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed."For around
three months, there were multiple cross-contamination events at the facility, it said.
"Your investigation failed to consider all impacted
batches, all manufacturing equipment involved, and the adequacy of your testing methods used to release contaminated drug products," USFDA
noted.
The US health regulator also pointed out that the company failed to adequately investigate and determine the root cause of glass
particulate contamination in multiple batches of Cyanocobalamin Injection (USP 1000mcg/mL, 1mL).
"Your firm failed to establish and follow
appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and
that include validation of all aseptic and sterilisation processes," it added.
USFDA sought a detailed remediation plan from the drug firm
with timelines to address the findings of the contamination hazards risk assessment.
"Based upon the nature of the violations we
identified at your firm, you should engage a consultant..
to assist your firm in meeting CGMP requirements," it added.
USFDA may withhold approval of new applications or supplements listing the
company as a drug manufacturer until deviations are completely addressed and it confirms compliance with CGMP.
"We may re-inspect to
verify that you have completed corrective actions to any deviations," USFDA said.
It further stated: "After you receive this letter,
respond to this office in writing within 15 working days
Specify what you have done to address any deviations and to prevent their recurrence."The warning letter issued by the USFDA usually
identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for
use.
The letter also makes clear that the company must correct the problem and provide directions and a timeframe of its plans for
correction.
FDA then checks to ensure that the company's corrections are adequate.(Only the headline and picture of this report may have
been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)First Published: Sep 15 2024
