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Contract Pharmacal Corp.

United States See location details
Last FDA Action: Apr 14, 2022

This drug manufacturing facility is registered with the FDA by Contract Pharmacal Corp.. ProPublica was able to identify at least 24 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
13 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 14, 2022
    Apr 14, 2022
    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.
  • Aug 15, 2017
    Aug 15, 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.
  • Dec 9, 2016
    Dec 9, 2016
    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.
  • Jan 8, 2015
    Jan 8, 2015
    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.
  • Dec 4, 2013
    Dec 4, 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.
    2 citations
    Procedures not in writing, fully followed
    The responsibilities and procedures applicable to the quality control unit are not in writing.
    Training--operations, GMPs, written procedures
    Employees are not given training in the particular operations they perform as part of their function.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Apr 8, 2013
    Apr 8, 2013
    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.
  • Feb 7, 2013
    Feb 7, 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.
    2 citations
    Establishment of time limitations
    Time limits are not established when appropriate for the completion of each production phase to assure the quality of 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.
  • Jan 25, 2012
    Jan 25, 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.
    3 citations
    Procedures not in writing, fully followed
    The responsibilities and procedures applicable to the quality control unit are not in writing.
    SOPs not followed / documented
    Written production and process control procedures are not followed in the execution of production and process control functions.
    Storage under appropriate conditions
    Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • May 20, 2011
    May 20, 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.
    7 citations
    Procedures not in writing, fully followed
    The responsibilities and procedures applicable to the quality control unit are not in writing.
    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.
    Scientifically sound laboratory controls
    Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that in-process materials conform to appropriate standards of identity, strength, quality and purity.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Oct 15, 2010
    Oct 15, 2010
    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 28, 2010
    Apr 28, 2010
    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
    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.
    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.
    SOPs not followed / documented
    Written production and process control procedures are not followed in the execution of production and process control functions.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Sep 10, 2009
    Sep 10, 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.
    2 citations
    Procedures To Be in Writing
    Written procedures are lacking which describe in sufficient detail the receipt, identification, storage, handling, sampling, testing, approval, and rejection of components, drug product containers, and closures.
    Quarantine of Rejected Components et. al.
    Rejected closures are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Jan 23, 2009
    Jan 23, 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.

Doxepin Hydrochloride

CompanyFlorida Pharmaceutical Products
Dosage
50mg
White (ivory/ivory) capsule marked with FPP 164
NDC: 71921-164-01

Doxepin Hydrochloride

CompanyFlorida Pharmaceutical Products
Dosage
10mg
White (buff/buff) capsule marked with FPP 162
NDC: 71921-162-01

Doxepin Hydrochloride

CompanyFlorida Pharmaceutical Products
Dosage
25mg
Ivory/white capsule marked with FPP 163
NDC: 71921-163-01

Doxepin Hydrochloride

CompanyFlorida Pharmaceutical Products
Dosage
75mg
Light green/light green capsule marked with FPP 165
NDC: 71921-165-01

Doxepin Hydrochloride

CompanyContract Pharmacal
Dosage
10mg
White (buff/buff) capsule marked with BSV 001
NDC: 10267-5059-X

Doxepin Hydrochloride

CompanyContract Pharmacal
Dosage
100mg
Light white, light green capsule marked with BSV 005
NDC: 10267-5063-X

Doxepin Hydrochloride

CompanyPd-rx Pharmaceuticals
Dosage
25mg
Ivory/white capsule marked with FPP 163
NDC: 72789-334-X

Doxepin Hydrochloride

CompanyBryant Ranch Prepack
Dosage
25mg
Ivory/white capsule marked with FPP 163
NDC: 72162-2227-1

Doxepin Hydrochloride

CompanyBryant Ranch Prepack
Dosage
75mg
Light green/light green capsule marked with FPP 165
NDC: 72162-2228-1

Doxepin Hydrochloride

CompanyBryant Ranch Prepack
Dosage
50mg
White (ivory/ivory) capsule marked with FPP 164
NDC: 71335-2408-X

Doxepin Hydrochloride

CompanyBryant Ranch Prepack
Dosage
25mg
Ivory/white capsule marked with FPP 163
NDC: 71335-1941-X

Doxepin Hydrochloride

CompanyFlorida Pharmaceutical Products
Dosage
100mg
Light green, light white capsule marked with FPP 166
NDC: 71921-166-01

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].