FDA Inspections Lawyers

FDA Inspections

What Compound Pharmacies, Outsourcing Facilities, Drug Manufacturers Need to Know About the Process

Over the past few years, many compound pharmacies have been subjected to aggressive action by the Food and Drug Administration (“FDA”). As a result of the fungal meningitis epidural case, the FDA declared that it “intends to continue proactive and for-cause inspections of compounding pharmacies, and plans to take aggressive action, including enforcement actions.”

Given the FDA’s warning and enforcement powers, compound pharmacies, outsourcing facilities and drug manufacturers should consider retaining an attorney to assist with FDA inspections.

      1. The FDA is an enforcement agency that has the power to bring enforcement action, including criminal prosecution (via the Department of Justice).
      2. Many inspections are conducted after receipt of a complaint or adverse event report. In these cases, the FDA is determined to find evidence of violations and may ask questions intended to draw out admissions of non-compliance.
      3. The FDA is often accompanied by investigators from the state Board of Pharmacy who have the power to discipline, even where the FDA does not.

Who is Subject to FDA Inspections?

Compound pharmacies are subject to FDA inspections; however, the standard for inspection differs depending on whether they are registered as an outsourcing facility (“503B”) or meet the 503A exemption from drug manufacturing regulations.

Compound pharmacies who compound for an identified individual patient and dispense upon receipt of a patient-specific prescription, are exempt from FDA registration, compliance with current Good Manufacturing Practices (CGMP), and labeling requirements, so long as they meet the 503A exemption requirement.

Generally, the FDA has limited interaction with these pharmacies; however, they will inspect these pharmacies if they receive a complaint or believe the pharmacy does not meet the 503A exemption.

Compound pharmacies registered as 503B outsourcing facilities are subject to FDA inspection on a risk-based schedule. Unlike 503A compounding pharmacies, these pharmacies must comply with CGMP regulations.

While compound pharmacies (not registered as outsourcing facilities) are exempt from CGMP regulations, this exemption rests on whether they can support each compound drug with a proper prescription for a specific patient. Compound pharmacies who fail to show the FDA investigator supporting prescriptions, will not be able to claim a 503A exemption, and will therefore be required to comply with CGMP and other regulations required of drug manufacturers.

Many compound pharmacies who believed they were exempted from CGMP, instead found themselves subject to discipline and enforcement action for non-compliance because their prescriptions did not meet the 503A exemption.

Common reasons for prescriptions failing the 503A exemption include:

    • Compounding and dispensing without receipt of a prescription
    • Compounding and dispensing without receipt of a prescription that identifies a specific patient
    • Compounding before receipt of a prescription when there is no pharmacists-physician relationship for orders regarding a specific patient
    • Compounds that deviate from the prescribed drug
    • Drugs made in bulk without a prescription
    • Compounding regular or inordinate amounts of drugs that are commercially available (compound pharmacies)
    • Compounding commercially available products (outsourcing facilities)
    • Compounding drugs that have been removed or withdrawn from the market by the FDA

Additionally, all compound pharmacies and manufacturers, regardless of 503A exemption status, are subject to FDA regulations regarding sanitary conditions and contamination. Several compound pharmacies and manufacturers have found themselves subject to enforcement action — including criminal action — for manufacturing contaminated drugs.

How do the FDA Inspections Commence?

The FDA has authority to inspect manufacturers and outsourcing facilities who have registered with the FDA. They can inspect compound pharmacies; however, inspections are limited to ensuring pharmacies meet the 503A exemption, review of sterile practices and for-cause inspections after receipt of a complaint.

The FDA usually does not announce for-cause inspections; however, they may pre-announce routine compliance inspections to ensure management and records will be present during the inspection. If the FDA arrives for an unannounced inspection, or attempts to arrange a pre-announced inspection, we strongly advise you contact our attorneys and arrange to have counsel present during the inspection.

While the FDA may threaten criminal prosecution upon any person who attempts to refuse or delay an authorized inspection, our attorneys may be able to work with the FDA to delay the inspection until an attorney has arrived without you being found to have refused or delayed the inspection.

What are Warrants and Consent to Inspect?

To inspect a facility, the FDA needs consent, an FDA Form 482 or an administrative warrant (also called an inspection warrant). If a search warrant is presented, the FDA is likely seeking to seize evidence of criminal wrongdoing. Likewise, if the FDA is accompanied by law enforcement, the facility is likely suspected of criminal violations.

What Can the FDA Inspect?

There are statutory limitations on what the FDA can inspect, copy and collect. Generally, they can review and copy records related to adulterated, misbranded or other alleged violations of the FD&C Act. However, they cannot review financial, sales, personnel and research data. The FDA may also photograph the facility to document compliance. If the FDA collects samples, they will need to issue a Form 484, which identifies the samples collected.

What are Deficiencies and FDA Form-483?

Upon completion of an FDA inspection, the investigator will issue an FDA Form-483, which outlines deficiencies found by the investigator. These deficiencies are objectionable and should be addressed before final action is taken by the FDA. Pharmacies may be able to reduce the chance of enforcement action and/or discipline by promptly submitting a corrective action plan to the FDA. Often, pharmacies respond by defending their actions, rather than directly addressing the FDA’s concerns and may fail to provide the FDA with evidence of compliance. In these cases, the FDA may find their response insufficient and move to take further action.

Common deficiencies include:

    • Improper sterilization practices
    • Inappropriate gowning of operators
    • Inadequate cleaning and disinfectant practices
    • Inappropriate air quality, humidity and pressure
    • Lack of air sampling logs
    • Insufficient product testing for potency or microbials
    • Inadequate or improper sterilization of containers
    • Improper temperature of incubators or insufficient temperature logs
    • Inadequate drug product batch failure investigations
    • Insufficient prescription records for compound drugs

What Are FDA Warning Letters?

The FDA has discretion to issue a warning letter, which is an informal advisory action that aims to bring prompt voluntary compliance with FDA regulations. While a warning letter is generally issued prior to enforcement action, the FDA can bring enforcement action concurrent with issuance of the warning letter.

In addition, a warning letter is not a prerequisite to enforcement action. Warning letters are often an opportunity to correct compliance issues and avoid enforcement action. Therefore, they should be taken seriously and dealt with promptly.

If the FDA does not receive a response, or the response is found to be inadequate, the FDA may move to take corrective action to correct the alleged violations.

What Are Injunctions and Temporary Restraining Orders?

In cases where significant violations have been found, the FDA will quickly seek an injunction or temporary restraining order (TRO) from the Federal Court. Injunctions are issued to control significant compliance issues that cause health hazards, gross consumer deception, or where seizure and/or voluntary recall have been or will be insufficient to protect the public, or for longstanding violations that have not been corrected after other efforts.

TROs are reserved for severe cases, such as conditions that pose a public health risk or cases involving companies that serve a significant portion of industry. If the FDA discovers significant violations, they will immediately compile evidence from the inspection, collect statements from investigators, and obtain an expert report and forward it to the DOJ, who will seek to have a federal court judge enter a TRO or injunction.

Once a TRO or injunction has been granted, the FDA will monitor the company for compliance. If the company violates an injunction or TRO, the FDA may seek criminal or civil contempt of court action, and/or regulatory actions.

There is a very short time frame in which you can respond to these orders. If you do receive a TRO or injunction, you should contact an attorney immediately to resolve the issue before it has a detrimental effect on the business, and/or leads to criminal prosecution.

What Other Enforcement Actions Can the FDA Take?

The FDA may also take additional action, concurrent with a TRO or injunction, such as:

  • Warning letters
  • Recalls and market withdrawals
  • Injunctions
  • Temporary Restraining Orders (TROs)
  • Suspension of part or all of the pharmacies operations
  • Civil Monetary Penalties (CMP)
  • Seizure of products in violation of regulations
  • Administrative detention of drugs
  • Criminal prosecutions for fraud, adulteration of drugs, misbranded drugs, counterfeit drugs, falsely labeling drugs, illegal promotion of drugs, falsely documenting drug studies, drug diversion, faulty surgical devices, etc.
  • License revocation

How Chapman Law Group Can Help

If you are aware of an FDA investigation, subject to an FDA inspection or are facing enforcement action by the FDA, contact the healthcare attorneys at Chapman Law Group immediately. 

Our healthcare defense and compliance attorneys can help demonstrate to the FDA that your pharmacy or facility is compliant, can respond to investigators’ questions, and will address subsequent action for deficiencies/violations.

If the FDA launches an onsite inspection, our lawyers will help ensure that the FDA does not exceed the scope of search authorized by statute or warrant. Additionally, we will help ensure that copies of records and duplicate samples of collected samples are retained in case there are later discrepancies or enforcement action.

Our lawyers will help prepare your response to a warning letter and will assist in preparing corrective action plans and communicating with the FDA during an open investigation. A prompt response that adequately demonstrates voluntary compliance may be sufficient to prevent further action. 

We have more than 30 years of experience in FDA inspection and health care compliance matters for clients throughout Michigan — Detroit, Troy, Dearborn, Ann Arbor and Grand Rapids, among several other communities  — and the Florida metro areas of Miami, Orlando, Tampa, West Palm Beach and Jacksonville. Contact us today. 

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