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# Megafine Pharma on Import Alert
- URL: https://www.fdaweb.com/megafine-pharma-on-import-alert/
- Published: 2016-05-31T12:00:00.000Z
- Updated: 2026-09-14T21:06:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135788

FDA says that Megafine Pharma, Mumbai, India, was placed on a 10/14/15 import alert due to findings from a 5/11-15/15 inspection showing significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API). A 5/19 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm503699.htm?ref=fdaweb.com) says that specific violations included: 

- failing to ensure that, for each batch of intermediate and API, appropriate laboratory tests are conducted to determine conformance to specifications;
- failing to prevent unauthorized access or changes to data and to provide adequate controls to prevent manipulation and omission of data; and
- inadequate investigation of critical deviations or a failure of a batch to meet its specifications or quality standards.

“Your quality system does not adequately ensure the adequacy and integrity of data to support the safety, effectiveness, and quality of drugs you manufacture,” the letter says. “We acknowledge that you are using a consultant to audit your operation and assist in meeting FDA requirements.” It lists information Megafine is to provide in its response.

The company was told to respond with a list of steps taken since the inspection to correct the deviations and prevent their recurrence.