Allergan's Hormigueros Facility Faces FDA Scrutiny

Strategic Insights -

The FDA's inspection of Allergan's facility in Hormigueros, Puerto Rico, resulted in a warning letter and regulatory documentation. The inspection was conducted from November 3 to December 22, 1998. Investigator Luis Soto-Lopez identified several deficiencies, including stability test failures, failure to submit field alert reports, and issues with the firm's ability to handle new drug applications. The firm's general manager, Jose Diaz, responded to the concerns by promising to address the issues and implement new procedures.

Key Takeaways:

  • The FDA inspection resulted in a warning letter and regulatory documentation, citing stability test failures, failure to submit field alert reports, and issues with the firm's ability to handle new drug applications.
  • Investigator Luis Soto-Lopez identified seven pages of 483 observations, highlighting the firm's deficiencies in stability programs, including ophthalmic suspensions and ointments.
  • The firm's general manager, Jose Diaz, acknowledged that the firm had failed to comply with international stability protocols, promising to establish the position of Stability Program Compliance Officer and reorganize the European Technical Center.
  • The inspection disclosed the firm's tinkering with a high-performance liquid chromatography assay, with Lopez noting that the change was prompted by a crystallization problem during preparation of the stock standard solution.
  • The firm's management informed Lopez that they intended to withdraw both NDA and ANDA applications, raising concerns about the firm's ability to handle regulatory submissions.
  • Diaz promised that the firm would develop a new SOP by March 1, 1999, addressing the stability test time points and that the procedure would be reviewed with the agency's office in San Juan.

Statistics:

  • The inspection was conducted from November 3 to December 22, 1998.
  • Investigator Luis Soto-Lopez documented 7 pages of 483 observations.
  • The firm's general manager, Jose Diaz, acknowledged failing to comply with international stability protocols.
  • The firm had 25 lots of Blephamide missing stability test results for the required intervals.
  • The firm's high-performance liquid chromatography assay was changed 17 times between November 1995 and February 1997.

Sources:

  • Doc. 7400W, March 9, 1999 warning letter
  • Doc. 108807M, inspection report, November 3-December 22, 1998.