> ## 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.

# CGMP Deviations Found in Mylan Unit 8
- URL: https://www.fdaweb.com/cgmp-deviations-found-in-mylan-unit-8/
- Published: 2019-11-12T12:00:00.000Z
- Updated: 2026-09-14T15:52:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145477

A 5/27-6/5 FDA inspection at Mylan Laboratories’ Unit 8, Andhra Pradesh, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). An 11/5 [Warning Letter](ttps://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mylan-laboratories-limited-unit-8-589297-11052019) says specific violations were: 

- failing to have adequate written procedures for the receipt, identification, and handling of raw materials; and
- failing to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the APIs beyond the official or other established specifications.

The letter says FDA strongly recommends that the firm engage a qualified consultant to evaluate its operation and assist it in meeting CGMP requirements. Mylan was told to respond with a list of specific steps taken since the inspection to correct the deviations and prevent their recurrence, with a schedule for completion of the steps.