Meridian Medical Technologies, Inc. a Pfizer Company FDA War

Detailed Analysis

False Claims and Regulatory Violations

Among other things, you manufacture two epinephrine auto-injectors at your facility, EpiPen and EpiPen Jr., (collectively, EpiPen products). These products are intended to deliver a lifesaving drug (epinephrine) during emergency treatment of serious allergic reactions, including anaphylaxis. If your auto-injectors do not operate as expected and deliver the intended amount of epinephrine drug when deployed in emergencies, patients can die or suffer serious illness. You failed to thoroughly investigate multiple serious component and product failures for your EpiPen products, including failures associated with patient deaths and severe illness. You also failed to expand the scope of your investigations into these serious and life-threatening failures or take appropriate corrective actions, un

We reviewed your firm's response and conclude that it is not adequate. Your firm plans to develop a procedure to assess performance variability and to require routine(b)(4)trending of reject levels at(b)(4)which will determine action limits based upon process capability. Your firm's response is not adequate because you have not provided this updated procedure with the aforementioned action limits, shown how you plan to use process capability in your analysis of processes, or indicated how this data will feed into your firm's corrective and preventive action system.

Potential Health Risks

In response to this letter, provide:• a comprehensive review of all your manufacturing investigations, including an evaluation of any other failures or discrepancies of a batch or any of its components that could potentially affect other products, whether or not they have been distributed or recalled; and• your plans for addressing the patient safety and product quality risks for product still in distribution.

Your procedures for handling complaints are inadequate. Your complaint classification scheme, listed in your standard operating procedure GPB-QS 1073Prioritization of Pfizer Product Quality Complaints, describes three classifications - expedite, high, and normal - for customer complaints. This complaint scheme is deficient because it does not prioritize complaints based on risk to patients, which your site quality leader acknowledged during the inspection.

In your response you stated that you would evaluate all complaint classifications and update your procedures. Your response is inadequate because you did not provide a sufficient rationale for how you determined which types of complaints fell into which categories. You did not discuss your plans for re-reviewing complaints previously categorized under this inadequate three-tiered scheme. Although you stated you would perform a risk assessment based on "medical" and "clinical" issues, you have not provided the results of this assessment, nor have you provided an updated risk classification scheme based on patient risk.

Regulatory Context

The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility, Meridian Medical Technologies, Inc. (MMT) at 2555 Hermelin Drive, Brentwood, Missouri, from February 20 to March 24, 2017. The products you manufacture at this facility are combination products under section 503(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 353(g) as your products include drug and device constituent parts.

This warning letter summarizes significant violations of current good manufacturing practice (CGMP) requirements for combination products. See 21 CFR part 4, 21 CFR parts 210 and 211 (drug CGMP), and 21 CFR part 820 (Quality System or QS Regulation).

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to drug CGMP requirements, 21 CFR parts 210 and 211, your combination products are adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351 (a)(2)(B).