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Pharmacia & Upjohn Company Llc

United States See location details
Last FDA Action: Jun 16, 2023

This drug manufacturing facility is registered with the FDA by Pfizer Inc. ProPublica was able to identify at least 38 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
14 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.

13 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.

  • Jun 16, 2023
    Jun 16, 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
    Authority lacking to review records, investigate errors
    The quality control unit lacks authority to fully investigate errors that have occurred.
    Buildings of Suitable Size, Construction, Location
    Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
    Cleaning System
    Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic conditions.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • May 20, 2021
    May 20, 2021
    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.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Dec 10, 2018
    Dec 10, 2018

    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.
  • Sep 21, 2018
    Sep 21, 2018
    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.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Nov 7, 2017
    Nov 7, 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.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Nov 12, 2015
    Nov 12, 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.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Jul 9, 2015
    Jul 9, 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.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Feb 28, 2014
    Feb 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.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Jun 20, 2013
    Jun 20, 2013
    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.
  • Aug 29, 2012
    Aug 29, 2012
    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 23, 2011
    Sep 23, 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.
  • Jun 3, 2011
    Jun 3, 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.
  • Sep 28, 2010
    Sep 28, 2010
    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.
  • Feb 18, 2009
    Feb 18, 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.
    4 citations
    Procedure Deviations Recorded and Justified
    Deviations from written production and process control procedures are not recorded and justified.
    SOPs not followed / documented
    Written production and process control procedures are not followed in the execution of production and process control functions.
    Procedures Written and Followed
    Procedures describing in sufficient detail the controls employed for the issuance of labeling are not written.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Oct 24, 2008
    Oct 24, 2008
    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.

Cleocin Pediatric

CompanyPharmacia & Upjohn Company
Dosage
Clindamycin Palmitate Hydrochloride
75mg/5mL
Cherry-flavored granule, for solution in a bottle (100mL)
NDC: 0009-0760-04

Cleocin T

CompanyPharmacia & Upjohn Company
Dosage
Clindamycin Phosphate
1%
Gel in a tube (30g)
NDC: 0009-1333-01

Cleocin T

CompanyPharmacia & Upjohn Company
Dosage
Clindamycin Phosphate
1%
Gel in a tube (60g)
NDC: 0009-1313-01

Colestipol Hydrochloride

CompanyMylan Pharmaceuticals
Dosage
5g/5g
Granule, for suspension in a packet (5g)
NDC: 59762-0260-X

Depo-estradiol

CompanyPharmacia & Upjohn Company
Dosage
Estradiol Cypionate
5mg/mL
Injection in a vial (5mL)
NDC: 0009-0271-01

Depo-testosterone

CompanyPharmacia & Upjohn Company
Dosage
Testosterone Cypionate
100mg/mL
Injection, solution in a vial (10mL)
NDC: 0009-0085-10

Depo-testosterone

CompanyPharmacia & Upjohn Company
Dosage
Testosterone Cypionate
200mg/mL
Injection, solution in a vial (1mL)
NDC: 0009-0086-X

Depo-testosterone

CompanyAsclemed Usa
Dosage
Testosterone Cypionate
100mg/mL
Injection, solution in a vial (10mL)
NDC: 76420-425-10

Depo-testosterone

CompanyPharmacia & Upjohn Company
Dosage
Testosterone Cypionate
100mg/mL
Injection, solution in a vial (10mL)
NDC: 0009-0347-02

Depo-testosterone

CompanyPharmacia & Upjohn Company
Dosage
Testosterone Cypionate
200mg/mL
Injection, solution in a vial (1mL)
NDC: 0009-0417-X

Dilantin Infatabs

CompanyParke-davis Div Of Pfizer
Dosage
Phenytoin
50mg
Yellow triangle tablet, chewable marked with PD 007
NDC: 0071-0007-X

Elelyso

CompanyPfizer Laboratories Div Pfizer
Dosage
Taliglucerase Alfa
200U/5mL
Injection, powder, lyophilized, for solution in a vial, glass (5mL)
NDC: 0069-0106-01

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].