Repeated Failures

What happens when a FDA regulated company has repeated failures during inspection or when promised corrective action does not appear to be effective? In a recent warning letter, FDA identified four citations: Releasing products to the US market without conducting finished product quality testing. Failure to verify the identity of drug components,...

What happens when a FDA regulated company has repeated failures during inspection or when promised corrective action does not appear to be effective?

In a recent warning letter, FDA identified four citations:

  1. Releasing products to the US market without conducting finished product quality testing.
  2. Failure to verify the identity of drug components, and verification of suppliers test analysis.
  3. Failure to establish and validate procedures for cleaning.
  4. Lack of SOPs relating to the quality unit functions.

While not numbered as an observation, the FDA also commented that the firm does not always follow their current SOPs.

Finally – FDA made the following observation:

Repeat observations at facility

In previous inspections, dated March 20, 2012, and December 19, 2014, FDA cited similar CGMP observations. You proposed specific remediation for these observations in your response. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate [bold and italic added by author].

Additionally, the firm was placed on import alert as of March 25, 2019.

Source: perfval.com