Last Updated on October 6, 2024 by The Health Master
USFDA warning letter
The US Food and Drug Administration (USFDA) has taken action against Intas Pharmaceuticals, citing several manufacturing lapses at its Sanand-based manufacturing plant.
In a warning letter dated July 28, 2023, the USFDA highlighted significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals.
1. USFDA’s Findings and Manufacturing Lapses
During an inspection conducted from November 22 to December 2, 2022, the USFDA uncovered various issues concerning Intas Pharmaceuticals’ manufacturing processes.
The warning letter raised concerns over the following lapses:
1. Quality Control Unit Failure:
The USFDA discovered that the company’s quality control unit did not ensure compliance with cGMP, resulting in adulterated drug products.
2. Data Reliability Issues:
Intas Pharmaceuticals failed to maintain reliable data related to the quality of medicines produced at its facility.
The inspection revealed several serious deviations, including:
- Inadequate oversight of original cGMP documents,
- Deficient controls over computerized systems,
- Insufficient laboratory investigations, and
- Aborted chromatographic sequences.
3. Data Integrity Deficiencies:
Senior facility managers did not exercise their authority and responsibility, leading to severe data integrity deficiencies in both the production and laboratory departments.
The USFDA’s investigators found torn and discarded original cGMP documents in various areas, raising significant concerns about data integrity.
4. Incomplete Laboratory Records:
The company did not ensure that laboratory records contained complete data derived from all tests necessary to ensure compliance with established specifications and standards.
There were instances of analysts entering manual integration events that yielded passing results without adequate procedural controls or justification.
2. Repeat Observations and Request for Investigation Protocol
The warning letter pointed out that similar cGMP observations were cited during previous inspections at the plant, including inspections conducted between May 20-28, 2019.
As a result, the USFDA has requested that Intas Pharmaceuticals provide a detailed investigation protocol and methodology, along with a summary of all laboratories, manufacturing operations, and systems to be covered by the assessment.
3. Consequences and Corrective Measures
The USFDA has warned Intas Pharmaceuticals that corrective actions must be promptly taken to address the identified violations.
Failure to do so may result in the USFDA withholding approval of new applications or supplements listing the company as a drug manufacturer.
The USFDA may also conduct re-inspections to verify that corrective actions have been completed.
Moreover, if the violations are not adequately addressed, the USFDA may continue to refuse admission of articles manufactured at the facility into the US market.
To facilitate the resolution process, Intas Pharmaceuticals is required to respond to the USFDA’s warning letter in writing within 15 working days.
The company must specify the actions taken to address the deviations and prevent their recurrence.
4. Importance of Warning Letters
A warning letter issued by the USFDA serves to identify violations and prompt the company to correct the problem promptly.
It also provides directions and a timeframe for the company’s plans for correction.
The USFDA closely monitors the company’s corrective actions to ensure they are sufficient and in compliance with CGMP regulations.
In conclusion, Intas Pharmaceuticals is now tasked with addressing the manufacturing lapses and data integrity issues pointed out by the USFDA in the warning letter.
Timely and effective corrective measures are crucial to ensure the company’s continued compliance with cGMP regulations and to prevent any disruptions in their operations and product approvals.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model, to rewrite and present the news / article in a unique format.
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