# FDA 483 - New England Life Care, Inc. - February 08, 2018

Source: https://www.keypedia.com/records/483/new-england-life-care-inc/99a957e4-29ff-4d18-a2a2-024c53cd6900

> FDA 483 for New England Life Care, Inc. on February 08, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: New England Life Care, Inc.
- Inspection Date: 2018-02-08
- Product Type: Drugs
- Office Name: New England District Office
- Summary: An FDA inspection of New England Life Care, Inc. was conducted from January 31 to February 8, 2018, revealing critical deficiencies in their sterile drug product manufacturing processes. The firm, a producer of sterile drug products, received an FDA 483 detailing multiple observations related to maintaining an aseptic environment.

Main violations included inadequate personnel aseptic technique, where technicians compromised ISO 5 classified aseptic processing areas by rapid movements, exposing bare skin, and failing to sanitize gloves. Environmental controls were found lacking, specifically with inadequate HEPA filter coverage and airflow; requalifications of laminar flow hoods did not accurately reflect operational setups, especially for Total Parenteral Nutrition (TPN) processing. A significant cross-contamination risk was identified due to insufficient segregation of beta-lactam drugs from other products, processed in the same hoods with only a wipe-down and no decontamination process for spills. Additionally, non-microbial contamination, such as stained ceiling tiles, was present in the production area, and non-sterile disinfectants were used for sanitizing critical ISO 5 aseptic processing hoods. These observations indicate non-compliance with good manufacturing practices, and New England Life Care, Inc. is required to implement thorough corrective actions to ensure product sterility and quality.

## Related Documents

- [483 - 2018-03-02](https://www.keypedia.com/records/483/new-england-life-care-inc/11705879-d460-4caa-9de6-a306a07a304c)

## Related Officers

- [Robert Mart](https://www.keypedia.com/people/robert-mart/3f383e61-6e72-42e2-b0d4-b10f0be4c53e)

Company: https://www.keypedia.com/companies/new-england-life-care-inc/a04cfb89-3771-4365-a9f1-ee62c6371586

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