Hikma Farmaceutica (portugal), S.a

Last FDA Action: Apr 21, 2023

This drug manufacturing facility is registered with the FDA by Hikma Farmaceutica (portugal), S.a.. ProPublica was able to identify at least 147 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.

9 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.

7 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.

Apr 21, 2023

Apr 21, 2023

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.

7 citations

Written calibration / inspection records not kept

Records of the calibration checks and inspections of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
Procedure Deviations Recorded and Justified

Deviations from written production and process control procedures are not recorded and justified.
Procedures for sterile drug products

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written.

View Inspector Notes
Inspector’s notes summarizing deficiencies observed during an inspection.
Feb 3, 2023

Feb 3, 2023

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.
Mar 6, 2020

Mar 6, 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.

ProPublica was unable to locate a 483 form detailing issues found in this inspection.
Mar 22, 2018

Mar 22, 2018

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 12, 2016

Apr 12, 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.

ProPublica was unable to locate a 483 form detailing issues found in this inspection.
Jun 19, 2015

Jun 19, 2015

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.

1 citation

Procedures for sterile drug products

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written.

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 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.

6 citations

Absence of Written Procedures

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
Procedures for sterile drug products

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written.
Deviations from laboratory control requirements

Deviations from written specifications and test procedures are not recorded and justified.

ProPublica was unable to locate a 483 form detailing issues found in this inspection.
Sep 29, 2011

Sep 29, 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.
Sep 24, 2009

Sep 24, 2009

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.

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.

Acyclovir

CompanyHikma Pharmaceuticals Usa

Dosage

Acyclovir Sodium

Injection, powder, lyophilized, for solution in a vial, single-dose (1)

NDC: 0143-9658-X

Acyclovir

CompanyHikma Pharmaceuticals Usa

Cefazolin

CompanyHenry Schein

Dosage

Cefazolin Sodium

225mg/mL

Injection, powder, for solution in a vial (2.2mL)

NDC: 0404-9835-99

12345...13

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.

What if I Find Something Concerning?

ProPublica does not provide medical advice. Keep in mind that if you turn up a troubling inspection report, it doesn’t necessarily mean that your drug is compromised. Doctors and pharmacists advise that you not stop taking your medications. Instead, you should talk to your health care provider about any concerns.

There are often different manufacturers of the same generic drug, and which manufacturer you get can depend on the pharmacy where you shop and what it has in stock. Changing the pharmacy where you fill your prescription might mean you can get a generic made by a different manufacturer.

The FDA maintains a database known as the FDA Adverse Event Reporting System that tracks reports about potential drug-quality problems and sudden and unexpected health conditions among consumers. Both health care professionals and consumers can report problems.

Although we cannot offer medical advice, our reporting team wants to hear from you. Please fill out this form to let us know what you find. We may follow up with future reporting.

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.

Hikma Farmaceutica (portugal), S.a

Facility Inspection History

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

7 citations

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

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

The FDA determined this facility was in an acceptable state.

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

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

1 citation

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

6 citations

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

The FDA determined this facility was in an acceptable state.

Drugs Manufactured Here

Frequently Asked Questions

What Do the Inspection Outcomes Mean?

What if I Find Something Concerning?

How Did ProPublica Connect This Information?

How Do I Report Incorrect Information?