ProPublica
Donate
New Search

Micro Labs Limited

India See location details
Last FDA Action: May 30, 2025

This drug manufacturing facility is registered with the FDA by Micro Labs Limited. ProPublica was able to identify at least 163 generic drugs that have been manufactured at this facility.

Facility Inspection History

The FDA is responsible for inspecting drug manufacturing facilities for violations of good manufacturing practices, such as a lack of documented drug quality testing or contaminated equipment. Below is a timeline of FDA inspections and outcomes for this facility assembled by ProPublica.

Note: ProPublica does not provide medical advice. Stopping your medication, doctors warn, can be dangerous. Please consult your doctor first if you have concerns. Read more
6 Known Inspections

The inspections we were able to locate using available FDA data do not include inspections in advance of the release of a new drug product.

4 Inspections Found Issues

When issues are observed, inspectors usually file an FDA 483 form with citations. In more serious cases, the FDA can issue warning letters or even ban the import of drugs from the facility.

  • May 30, 2025
    May 30, 2025
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    2 citations
    Control procedures to monitor and validate performance
    Control procedures are not established which 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.
    Investigations of discrepancies, failures
    There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Feb 9, 2024
    Feb 9, 2024

    An inspector documented issues at the facility.

    We were unable to connect this 483 form to an FDA inspection designation, but we do know that an inspector filed this form observing problem(s).
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Feb 15, 2019
    Feb 15, 2019
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Apr 19, 2017
    Apr 19, 2017

    An import ban on the facility lifted some time after this date.

    The FDA doesn't publish a historic record of import alerts, but the last time we saw this facility on archived import bans lists was Apr 19, 2017.
  • Apr 14, 2017
    Apr 14, 2017
    Inspection

    The FDA determined this facility was in an acceptable state.

    This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors.
  • Sep 19, 2014
    Sep 19, 2014
    Import Ban

    The FDA banned the import of medications from this facility.

    An import alert was issued for this facility, meaning the FDA had reason to believe products manufactured there violated FDA manufacturing standards and should not be allowed into the country.
  • May 13, 2014
    May 13, 2014
    Inspection With Issues

    The FDA ruled the facility was in an “unacceptable state of compliance.”

    Inspectors found serious issues at the facility, and the agency ultimately recommended official compliance action. In cases like this, the FDA typically pauses the facility’s pending drug approvals. There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Nov 17, 2011
    Nov 17, 2011
    Inspection

    The FDA determined this facility was in an acceptable state.

    This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors.
  • Apr 17, 2009
    Apr 17, 2009
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.

Drugs Manufactured Here

Below is a list of generic prescription drugs that we’ve been able to connect to this facility. Brand name and over-the-counter drugs, as well as labels we were unable to trace, are not included here.

Acetazolamide Extended-release

CompanyMicro Labs
Dosage
Acetazolamide
500mg
Orange capsule marked with M 26
NDC: 42571-243-01

Acetazolamide Extended-release

CompanyAvpak
Dosage
Acetazolamide
500mg
Orange capsule marked with M 26
NDC: 50268-042-X

Amlodipine And Olmesartan Medoxomil

CompanyMicro Labs
Dosage
Amlodipine Besylate
5mg
Olmesartan Medoxomil
20mg
White round tablet marked with 81 I
NDC: 42571-235-X

Amlodipine And Olmesartan Medoxomil

CompanyMicro Labs
Dosage
Amlodipine Besylate
10mg
Olmesartan Medoxomil
40mg
Brownish red round tablet marked with 84 I
NDC: 42571-238-X

Amlodipine And Olmesartan Medoxomil

CompanyMicro Labs
Dosage
Amlodipine Besylate
10mg
Olmesartan Medoxomil
20mg
Grayish orange round tablet marked with 83 I
NDC: 42571-236-X

Amlodipine And Olmesartan Medoxomil

CompanyMicro Labs
Dosage
Amlodipine Besylate
5mg
Olmesartan Medoxomil
40mg
Yellow (cream) round tablet marked with 82 I
NDC: 42571-237-X

Amlodipine And Olmesartan Medoxomil

CompanyBryant Ranch Prepack
Dosage
Amlodipine Besylate
5mg
Olmesartan Medoxomil
20mg
White round tablet marked with 81 I
NDC: 72162-2379-X

Aspirin And Extended-release Dipyridamole

CompanyMicro Labs
Dosage
Aspirin
25mg
Dipyridamole
200mg
Red colored cap and ivory colored body capsule-shaped capsule, extended release marked with M25
NDC: 42571-274-60

Aspirin And Extended-release Dipyridamole

CompanyBryant Ranch Prepack
Dosage
Aspirin
25mg
Dipyridamole
200mg
Red colored cap and ivory colored body capsule-shaped capsule, extended release marked with M25
NDC: 63629-5045-1

Atorvastatin Calcium

CompanyMicro Labs
Dosage
Atorvastatin Calcium Trihydrate
20mg
White to off-white oval tablet, film coated marked with I 91
NDC: 42571-173-X

Atorvastatin Calcium

CompanyMicro Labs
Dosage
Atorvastatin Calcium Trihydrate
80mg
White to off-white oval tablet, film coated marked with I 93
NDC: 42571-175-X

Atorvastatin Calcium

CompanyMicro Labs
Dosage
Atorvastatin Calcium Trihydrate
10mg
White to off-white oval tablet, film coated marked with I 90
NDC: 42571-172-X

Frequently Asked Questions

What Do the Inspection Outcomes Mean?
These are the possible FDA compliance outcomes we highlight:
  • Import alert. This is rare and means drugs from this facility were banned from coming into the U.S. Specifically we are including alerts relating to FDA manufacturing standards for drug products. The agency sometimes exempts certain drugs from import bans, ostensibly to prevent drug shortages.
  • Warning letter. This is a disciplinary tool the FDA uses to lay out significant violations of federal requirements. The company has an opportunity to respond and/or provide its plans to correct the issues. The agency might later issue a “close-out letter” to say it has confirmed that issues raised in a previous warning letter were fixed. But that doesn’t always happen.
  • Unacceptable state of compliance. This means inspectors found serious issues at the facility and the agency ultimately recommended official compliance action. In cases like this, the FDA typically pauses the facility’s pending drug approvals. The agency classifies this as “official action indicated.”
  • Some issues found, but no further FDA action. This is very common. It means the FDA found issues but determined the facility can correct them voluntarily. In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time. The agency classifies this as “voluntary action indicated.”
  • Inspector documented issues. Inspectors can file notes summarizing deficiencies observed during an inspection using a 483 form. In some cases, we’re unable to connect a Form 483 to an FDA inspection designation, but we show that an inspector filed this form, perhaps as part of an inspection that was not included in the public inspection dashboard.
  • Acceptable state. This is common and the best possible outcome for an inspection. This means the FDA took no compliance action and ProPublica found no issues documented by inspectors. That doesn’t always mean no issues turned up. Sometimes, inspectors address concerns with management on site that they believe do not need to be documented on a 483. The agency classifies this as “no action indicated.”
There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public.

How Did ProPublica Connect This Information?
We have written an in-depth methodology, but in short, we connected several FDA databases:
  • The Structured Product Labeling database.
  • The National Drug Code Directory.
  • The Electronic Drug Registration and Listing System.
  • Data from the agency’s inspection dashboard.
  • A spreadsheet of facility addresses we sued the FDA for, which connected them to drug application numbers.
  • Form 483 documents we received from a Freedom of Information Act Request.
ProPublica described the app and the methodology used to build it to the FDA, which did not comment. The agency previously told ProPublica that it doesn’t reveal where drugs are made on inspection reports to protect what it deemed confidential commercial information.

How Do I Report Incorrect Information?
If you work for a manufacturer or otherwise see that information we are displaying may be incorrect, please email [email protected].