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

Source: https://www.keypedia.com/records/483/new-england-compounding-pharmacy-inc/81595ff8-c7cb-4670-b6e0-746ba6fcb52f

> FDA 483 for New England Compounding Pharmacy, Inc. on February 10, 2003. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: New England Compounding Pharmacy, Inc.
- Inspection Date: 2003-02-10
- Product Type: Drugs
- Office Name: New England District Office
- Summary: 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

## Related Documents

- [483 - 2002-04-16](https://www.keypedia.com/records/483/new-england-compounding-pharmacy-inc/0b17acd0-4d61-4ce0-9b72-dcf50d86d687)
- [MEMO - 2003-02-05](https://www.keypedia.com/records/memo/new-england-compounding-pharmacy-inc/6a7d0002-1eab-4839-aba1-a1ba38ed07f2)

## Related Officers

- [Deputy Office Director, FDA/CDRH OHT3](https://www.keypedia.com/people/kristina-m-joyce/88cb1fde-ef0b-41d9-8cdf-978638ac537f)
- [Darryl Dewoskin](https://www.keypedia.com/people/darryl-dewoskin/f101f9fe-942b-4873-8baa-fdfee2fc3375)

Company: https://www.keypedia.com/companies/new-england-compounding-pharmacy-inc/2675bcaf-ff3b-4098-9519-16bb00231dcd

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144