FDA 483 - New England Compounding Pharmacy, Inc. - February 10, 2003

This FDA Form 483 was issued to New England Compounding Center, a pharmacy located at 697 Waverly Street, Framingham, MA 01702, following inspections conducted on 10/24, 12/12&18/02, 1/14-15/03, and 2/10/03. The report was issued to Barry J. Cadden, Director of Pharmacy.

The observations pertain to sterile drug products (e.g., injections) prepared in anticipation of a prescription. Key violations include:

1. **Inadequate Documentation for Sterile Drug Products:** No adequate documentation was available to verify that sterile drug products met set standards (specifications/USP limits) at distribution or throughout their shelf life. This includes lack of documentation for: * Prevention of contamination by personnel, workspaces, and equipment/supplies. * Environmental monitoring in product preparation areas. * Suitability of autoclave sterilization processes (critical parameters, maintenance, calibration, and impact on stability/specifications). * Prevention of contamination during transfer of bulk drug product and equipment. * Suitability of components (drug substances, vials, stoppers) and process water. * Calibration and maintenance of ingredient measuring equipment. * Representativeness of testing and sampling procedures. * Laboratory determination of conformity with