FDA HITS HAWKINS WITH WARNING LETTER

Deviations from current good manufacturing practices by chemical company Hawkins caused active pharmaceutical ingredients (APIs) to become contaminated when they were repackaged and relabeled, the FDA said in a warning letter to the company.

According to the FDA, the company repackages and relabels APIs for further distribution for use in pharmacies for compounding of drugs. The warning letter, issued Sept. 8 and posted Sept. 28 on the agency's website, listed seven "significant" deviations the FDA said it found during inspections conducted in March and April of this year. According to the agency, the company's deviations include failures to:

Demonstrate the adequacy of its system to indicate when an API is set to expire and should be retested;

Show on the certificate of quality that Hawkins issues with the repackaged APIs the name, address and telephone number of the laboratory that performed the API quality analysis;

Periodically validate the authenticity of the API suppliers' certificates of authenticity;

Indicate on the certificates the name and address of the original API manufacturer;

Conduct audits of contract laboratories that perform testing of incoming APIs, which Hawkins is supposed to do every two years, according to the agency;

Maintain written procedures that describe the responsibilities and procedures applicable to Hawkins' quality control unit;

Retain reserve samples of each batch of APIs that Hawkins repackages; and

Document that air filters in repackaging areas are changed according to schedule.

The company did not respond to a request for comment.

The letter can be found at: www.fda.gov/foi/warning_letters/g6022d.pdf (http://www.fda.gov/foi/warning_letters/g6022d.pdf).