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# Divi’s Laboratories Inspection Observations
- URL: https://www.fdaweb.com/divis-laboratories-inspection-observations/
- Published: 2017-09-28T12:00:00.000Z
- Updated: 2026-09-14T22:53:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139732

FDA has released the FDA-483 [issued](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM577509.pdf?ref=fdaweb.com) following a 9/11-9/19 inspection at Divi’s Laboratories, Andhra Pradesh, India, an active pharmaceutical ingredient (API) manufacturer. Specific observations listed were: 

- failing to test individual batches of final API for conformity with all appropriate specifications such as purity, strength, and identity;
- failing to thoroughly investigate laboratory failures;
- review of analytical incident/excursion investigations per the company’s atypical or out-of-trend-results procedure showed instances in which samples injection sequence was completed but results were not calculated and/or compared to specifications to ensure OOS results were not obtained and sample result screening is not occurring prior to invalidating the run for system suitability or chromatograph issues;
- failing to validate the manufacturing cleaning length of time in situations that are redacted from the form;
- failing to have adequate specified cleaning instructions for the major equipment in the pharma block; and
- failing to record contemporaneously batch records at the completion of an operation.