Warning letter

from Wikipedia, the free encyclopedia

A Warning Letter ( dt. Warning , written warning or warning notice ) is a written communication from the Food and Drug Administration (FDA).

description

The FDA is in the United States the authority responsible for the Public Health is responsible. The area of ​​responsibility includes, among other things, the monitoring of food and pharmaceuticals , as well as their production and approval ; medical devices , cosmetics and tobacco products . The FDA is endowed with far-reaching powers, which, among other things, enable the inspection and review of production facilities of companies. These inspections, also known as FDA audits, can also be performed on companies located outside of the United States or with manufacturing facilities if their products are sold in the United States. In the food and pharmaceuticals sector, the so-called Good Manufacturing Practice (GMP) is the central guideline for quality assurance in production processes and the environment.

If deficiencies are found during the inspection of a company, these are first noted by the inspectors on the so-called Form 483 ( Inspectional Observations ) (level 1). After the inspection, the responsible inspector creates an Establishment Inspection Report (EIR). If the deviations in the manufacturing process are classified as significant in the EIR , or if the manufacturer's statement on remedying the defects complained about is classified as inadequate, the FDA sends a warning letter (level 2). This is particularly the case of very dramatic deviations from the GMP compliance ( GMP compliance ) or repeated violations without initiation of corrective action the case.

The company contacted usually has 15 working days to respond in writing to the warning letter after receiving the warning letter . The recipient can speak and discuss the contents of the letter with official FDA representatives. In the reply, the FDA expects a catalog of measures to remedy the deficiencies listed in the warning letter .

If, in the opinion of the FDA, the company contacted does not provide a satisfactory response to the warning letter , the inspected production site may no longer produce any product for the US market (level 3). In addition, the FDA can ban all other company's products that are not objected to in the audit from being imported into the United States if it has doubts about the manner in which the quality standards are being handled.

The Freedom of Information Act (FOIA) in the United States gives every US citizen the right to request access to United States law enforcement documents. For this reason, the FDA Warning Letters are published on the Internet . Only sensitive information relating to products or processes is removed. This publicity puts considerable pressure on the company that received the warning letter , or generally in the run-up to every FDA audit . The release may also affect the affected company's share price, particularly because of the possible third stage of FDA action.

example

The FDA issued a warning letter to Poly Implant Prothèse in 2000 and subsequently banned the company from exporting its breast implants to the United States.

Individual evidence

  1. ↑ The FDA's definition is:

    A Warning Letter is a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations and other federal statutes. Warning letters should only be issued for violations of regulatory significance, ie, those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency's principal means of achieving prompt voluntary compliance with the Act.

    - Procedures for Clearing FDA Warning Letters and Untitled Letters. (PDF; 590 kB) As of December 2010
  2. ↑ E. Wintermantel, Suk-Woo Ha: Medical technology. Edition 5, Springer, 2009, ISBN 3-540-93935-0 , p. 2160 ( limited preview in the Google book search).
  3. ↑ a b R. J. Gengenbach: GMP qualification and validation of active ingredient plants. John Wiley & Sons, 2009, ISBN 3-527-62628-X , p. 40 ( limited preview in Google book search).
  4. ↑ Procedures for Clearing FDA Warning Letters and Untitled Letters. (PDF; 590 kB) As of December 2010
  5. ↑ Overview of FDA Warning Letters in the manufacture of sterile drugs. Retrieved February 17, 2012
  6. ↑ Current trend in FDA warning letters. Retrieved February 17, 2012
  7. ↑ J. Walter: Implementing business process management. Hanser Verlag, 2009, ISBN 3-446-41801-6 , p. 216 ( limited preview in Google book search).
  8. ↑ RJ Gengenbach: GMP qualification and validation of active ingredient plants. John Wiley & Sons, 2009, ISBN 3-527-62628-X , pp. 63–64 ( limited preview in Google book search).
  9. ↑ Lack of patient safety with medical devices. (PDF; 229 kB) Response of the Federal Government to the minor question from MPs Maria Klein-Schmeink, Harald Terpe, Birgitt Bender, other MPs and the Alliance 90 / THE GREENS parliamentary group - printed matter 17/8403, dated February 6, 2012
  10. ↑ A. Brandt, K. Elger and others: Trash with seal . In: Der Spiegel . No. 3 , 2012, p. 42 ( online ).

Web links