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Sheffield Pharmaceuticals Llc

United States See location details
Last FDA Action: Jun 18, 2025

This drug manufacturing facility is registered with the FDA by Sheffield Pharmaceuticals Llc. ProPublica was able to identify at least 8 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
7 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.

6 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 18, 2025
    Jun 18, 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.
    5 citations
    Buildings not maintained in good state of repair
    Buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained in a good state of repair.
    Items to cover on annual reviews
    Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products, and investigations conducted for each 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.
  • Mar 15, 2019
    Mar 15, 2019

    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 25, 2018
    Sep 25, 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.
    4 citations
    Procedures not in writing, fully followed
    The responsibilities and procedures applicable to the quality control unit are not in writing.
    Written procedures not established/followed
    Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
    Items to cover on annual reviews
    Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products, and investigations conducted for each drug product.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Feb 18, 2016
    Feb 18, 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.
    2 citations
    Complaint Handling Procedure
    Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
    Failure to develop written procedures
    Written procedures have not been developed for the surveillance, receipt, evaluation, and reporting to FDA of postmarketing adverse drug experiences.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Mar 19, 2015
    Mar 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.
    8 citations
    Training--operations, GMPs, written procedures
    Employees are not given training in the particular operations they perform as part of their function.
    Representative Samples
    Representative samples are not taken of each shipment of each lot of components, drug product containers, and closures for testing or examination.
    Reports of Analysis (Components)
    Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Apr 13, 2012
    Apr 13, 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.
    5 citations
    Procedures not in writing, fully followed
    The responsibilities and procedures applicable to the quality control unit are not in writing.
    Procedures for non-sterile drug products
    Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.
    Calibration - at intervals, written program, remedial action
    The calibration of instruments is not done at suitable intervals in accordance with an established written program and with provisions for remedial action in the event accuracy and/or precision limits are not met.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Dec 2, 2010
    Dec 2, 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.
  • Sep 16, 2009
    Sep 16, 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.

Sf

CompanyCypress Pharmaceutical
Dosage
Sodium Fluoride
1.1%
Blue fresh mint-flavored gel in a tube (56g)
NDC: 60258-151-01

Sf 5000 Plus

CompanyCypress Pharmaceutical
Dosage
Sodium Fluoride
0.5%
Blue mint-flavored cream in a tube (51g)
NDC: 60258-150-01

Sodium Fluoride 5000 Ppm Dry Mouth

CompanySheffield Pharmaceuticals
Dosage
Sodium Fluoride
0.61%
Blue mint-flavored gel, dentifrice in a tube (100mL)
NDC: 11527-755-34

Sodium Fluoride 5000 Ppm Enamel Protect

CompanySheffield Pharmaceuticals
Dosage
Potassium Nitrate
5.75%
Sodium Fluoride
0.58%
White mint-flavored gel, dentifrice in a tube (100mL)
NDC: 11527-745-34

Sodium Fluoride 5000 Ppm Fruit

CompanySheffield Pharmaceuticals
Dosage
Sodium Fluoride
0.6%
Pink fruit-flavored paste, dentifrice in a tube (100mL)
NDC: 11527-730-44

Sodium Fluoride 5000 Ppm Sensitive

CompanySheffield Pharmaceuticals
Dosage
Sodium Fluoride
0.58%
Potassium Nitrate
5.75%
Green peppermint-flavored gel, dentifrice in a tube (100mL)
NDC: 11527-704-42

Sodium Fluoride 5000 Ppm Spearmint

CompanySheffield Pharmaceuticals
Dosage
Sodium Fluoride
0.6%
Blue spearmint-flavored paste, dentifrice in a tube (100mL)
NDC: 11527-750-43

Wentworth Alcohol Free

CompanySheffield Pharmaceuticals
Dosage
Sodium Fluoride
0.09%
A clear blue solution mint-flavored mouthwash in a bottle, plastic (473mL)
NDC: 11527-735-16

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].