ProPublica
Donate
New Search

Ophtapharm Ag

Switzerland See location details
Last FDA Action: Feb 28, 2020

This drug manufacturing facility is registered with the FDA by Ophtapharm Ag. ProPublica was able to identify at least 14 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
5 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.

5 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.

  • Feb 28, 2020
    Feb 28, 2020
    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.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
    3 citations
    Supervisor Training/Education/Experience
    Individuals responsible for supervising the manufacture, processing, packing, and holding of a drug product lack the training to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess.
    Changes to Procedures Not Reviewed, Approved
    Changes to written procedures are not reviewed and approved by the quality control unit.
    Actual vs. theoretical yields not determined
    Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of manufacturing of the drug product.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Dec 12, 2017
    Dec 12, 2017
    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.
    4 citations
    Aseptic Processing Area
    Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.
    Cleaning SOPs/instructions
    Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.
    Test methods
    The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • May 25, 2016
    May 25, 2016
    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.
    5 citations
    Procedures not in writing, fully followed
    The responsibilities and procedures applicable to the quality control unit are not in writing.
    Procedures for sterile drug products
    Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written.
    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.
  • Mar 28, 2014
    Mar 28, 2014
    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.
    3 citations
    Cleaning / Sanitizing / Maintenance
    Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
    Procedures for sterile drug products
    Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written.
    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.
  • Nov 9, 2011
    Nov 9, 2011
    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.

Brimonidine Tartrate/timolol Maleate

CompanyArmas Pharmaceuticals
Dosage
Brimonidine Tartrate
0.2%
Timolol Maleate
0.5%
Solution/ drops in a bottle, dropper (5mL)
NDC: 72485-634-X

Bromfenac

CompanyArmas Pharmaceuticals
Dosage
Bromfenac Sodium
0.1%
Clear, yellow to orange yellow solution/ drops in a bottle, dropper (1.7mL)
NDC: 72485-649-71

Ciprofloxacin And Dexamethasone

CompanyArmas Pharmaceuticals
Dosage
Ciprofloxacin Hydrochloride
0.3%
Dexamethasone
0.1%
Suspension/ drops in a bottle, dropper (7.5mL)
NDC: 72485-625-13

Ciprofloxacin And Dexamethasone

CompanyRedpharm Drug
Dosage
Ciprofloxacin Hydrochloride
0.3%
Dexamethasone
0.1%
Suspension/ drops in a bottle, dropper (8mL)
NDC: 67296-1943-8

Erythromycin

CompanySt. Mary's Medical Park Pharmacy
Dosage
0.5%
Ointment in a tube (3.5g)
NDC: 60760-670-35

Erythromycin

CompanyArmas Pharmaceuticals
Dosage
0.5%
Ointment in a tube (3.5g)
NDC: 72485-670-X

Erythromycin

CompanyRedpharm Drug
Dosage
0.5%
Ointment in a tube (3.5g)
NDC: 67296-2128-3

Lidocaine

CompanyArmas Pharmaceuticals
Dosage
Lidocaine Hydrochloride
2%
Jelly in a tube (5mL)
NDC: 72485-611-X

Loteprednol Etabonate

CompanyArmas Pharmaceuticals
Dosage
0.2%
White to off white suspension/ drops in a bottle, dropper (5mL)
NDC: 72485-653-X

Loteprednol Etabonate

CompanyArmas Pharmaceuticals
Dosage
0.5%
Gel in a bottle, dropper (5g)
NDC: 72485-630-05

Loteprednol Etabonate

CompanyArmas Pharmaceuticals
Dosage
0.5%
White to off white suspension/ drops in a bottle, dropper (5mL)
NDC: 72485-665-X

Ofloxacin

CompanyArmas Pharmaceuticals
Dosage
0.3%
Solution/ drops in a bottle, dropper (5mL)
NDC: 72485-613-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].