The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs / Inspections and Audits

Chinese Contract Manufacturer Warned On Sterilization Validation

Dec. 13, 2013

Synecco, a China-based contract manufacturer and contract sterilizer, received an FDA warning letter for shortfalls in sterilization validation and other GMP issues.

The company failed to specify parameters for sterilization temperature, vacuum pressure, humidity and aeration time in a sterilization validation protocol, according to the Nov. 18 letter recently posted online. Synecco also did not specify the pressures used in sealing film pouches used to package certain sterile syringes.

Synecco’s products include feeding tubes, sterile enteral feeding tubes, sterile gastrointestinal tubes and accessories, sterile syringe pistons and liquid medication dispensers distributed in the U.S.

Other sterilization validation problems include:

  • Misidentifying the sterilization chamber for certain products in a sterilization validation report;

  • Failing to identify the name of a validated product and sampling size on a sealing validation report;

  • Failing to identify the name of the validated product, batch/lot, temperatures, pressure and sealing hold time on sealing validation test records; and

  • Failing to list the title of officials preparing, reviewing and approving validation protocols and reports in documents.

CAPA deficiencies also drew the FDA’s attention. For one corrective action report for a syringe, the company did not identify the necessary corrective and preventive action, the letter says.

Meanwhile, complaints received between May 02, 2012, and June 20, 2013, lacked the complaint receipt date, the complaint source, complainant feedback such as who and when, root cause and date of complaint disposition.

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