> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Aurobindo FDA-483 Has 11 Observations
- URL: https://www.fdaweb.com/aurobindo-fda-483-has-11-observations/
- Published: 2019-04-09T12:00:00.000Z
- Updated: 2026-09-15T01:19:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143816

FDA has released the FDA-483 issued following a 2/22-3/1 inspection at Aurobindo Pharma, Telangana, India. The 11 specific observations on the [form](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM635455.pdf?ref=fdaweb.com) were: 

- failing to fully follow responsibilities and procedures applicable to the quality control unit;
- failing to establish control procedures that monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product;
- failing to thoroughly review any unexplained discrepancy whether or not the batch has already been distributed;
- employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- failing to establish and follow procedures to prevent microbiological contamination of drug products purporting to be sterile;
- failing to have laboratory controls include establishment of scientifically sound and appropriate specifications and sampling plans designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity;
- failing to exercise appropriate controls over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel;
- failing to have written procedures describing in sufficient detail component sampling and testing;
- failing to have component records include the identity and quantity of each shipment of each lot, name of the supplier, supplier’s lot number, and date of receipt; and
- failing to document the accuracy, sensitivity, and specificity of test methods.