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# Divi’s Laboratories Inspection Finds API Deviations
- URL: https://www.fdaweb.com/divis-laboratories-inspection-finds-api-deviations/
- Published: 2017-04-25T12:00:00.000Z
- Updated: 2026-09-14T22:19:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138526

A 11/26-12/6/16 FDA inspection at Divi’s Laboratories, Andhra Pradesh, India, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients, according to a 4/13 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm554576.htm?ref=fdaweb.com). The agency also documented that the firm limited and/or refused an FDA inspection, the letter says. Specific deviations included: 

- failing to ensure that test procedures are scientifically sound and appropriate to ensure that API conform to established standards of quality and/or purity;
- failing to prevent unauthorized access or changes to data and failing to provide adequate controls to prevent manipulation and omission of data; and
- limiting access to or copying of records.

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

The company was told to submit **(1)** a comprehensive investigation into the extent of inaccuracies in data records and reporting; **(2)** a current risk assessment of the potential effects of the observed failures on the quality of the firm’s drugs; and **(3)** a management strategy that includes details of a global corrective action and preventive action plan. It also was told to respond with a list of specific actions taken since the inspection to correct the violations and prevent their recurrence, and a timetable for completion. FDA placed Divi’s on two import alerts on 3/20.