Last Updated on August 10, 2023 by The Health Master
USFDA warning letter
1. USFDA’s Findings and Manufacturing Lapses
The warning letter raised concerns over the following lapses:
1. Quality Control Unit Failure:
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.
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
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
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
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.
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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