> ## 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.

# Biotek India CGMP Violations
- URL: https://www.fdaweb.com/biotek-india-cgmp-violations/
- Published: 2021-05-25T12:00:00.000Z
- Updated: 2026-09-14T17:00:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149391

An FDA review of records submitted at the agency’s request by Biotek India, Gujarat, India, and other information has identified significant violations of current good manufacturing practice (CGMP) regulations. A 5/13 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/biotek-india-613295-05132021?ref=fdaweb.com) says the violations are: 

- failing to have for each batch of drug product appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, before release;
- failing to conduct at least one test to verify the identity of each component of a drug product; and
- failing to establish and follow an adequate written testing program designed to assess the stability characteristic of drug products and to use the results of stability testing to determine appropriate storage conditions and expiration dates.

The letter also says the firm’s over-the-counter 99% isopropyl rubbing alcohol is a misbranded unapproved new drug. The letter says the product does not conform to a 1991 tentative final monograph on topical antimicrobial drug products for over-the-counter use or any other tentative final monograph, proposed rule, or final rule. In addition, it says that 99% is not a permitted concentration for use in first aid antiseptics under the 1991 tentative final monograph.

FDA recommends that Biotek India engage a qualified consultant to perform a comprehensive audit of its entire operations for CGMP compliance, assist the firm in meeting CGMP requirements, and evaluate the completion and efficacy of its corrective and preventive actions before Biotek pursues resolution of its compliance status with FDA.

The agency placed the firm’s product on a 3/10 import alert.

Biotek was told to respond with a list of steps it has taken since the inspection to address any deviations and violations and to prevent their recurrence, with a timetable for completing the actions.