# FDA 483 - New England Home Therapies, Inc - September 24, 2014

Source: https://www.keypedia.com/records/483/new-england-home-therapies-inc/07b2b8c3-9a09-4ac9-9ff3-09ad88b8417b

> FDA 483 for New England Home Therapies, Inc on September 24, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: New England Home Therapies, Inc
- Inspection Date: 2014-09-24
- Product Type: Drugs
- Office Name: New England District Office
- Summary: This FDA Form 483 details multiple deficiencies observed during an inspection.

**Personnel and Facility:**
*   Cleanroom operators' attire was inappropriate; non-sterile gowns/coveralls, face masks, hair bonnets, and goggles/glasses were used or improperly worn. Operators used non-sterile hand antiseptic before and after donning sterile gloves. Gowns touched the floor during donning.
*   The ante room sink, used for handwashing, was leaking from the pipe.

**Aseptic Processing and Environmental Control:**
*   The firm lacked cleaning efficacy studies for disinfectants used in ISOS zones, cleanroom, and ante room.
*   A sporicidal agent was not routinely used for ISOS hoods.
*   Non-sterile wipers were used for disinfection in ISOS zones and equipment, with no information on non-shedding properties.
*   Environmental monitoring (viable and non-viable particulates) was not conducted during aseptic processing in ISO 5 zones.
*   Personnel monitoring was not conducted daily after aseptic processing/cleanroom exit, and did not include forearms, forehead, chest, or goggles/glasses.
*   Molds/yeasts for work surface monitoring were not incubated at the manufacturer's recommended 20-25°C.

**Product Testing and Contamination Prevention:**
*   Injectable finished drug products were not tested for assay or sterility prior to release.
*   The firm processed

## Related Documents

- [483 - 2016-01-27](https://www.keypedia.com/records/483/new-england-home-therapies-inc/c54c1def-f203-40db-bc9e-bf8ae0d6faba)
- [STATE_REFERRAL_LETTER - 2016-01-11](https://www.keypedia.com/records/state_referral_letter/new-england-home-therapies-inc/68628572-1b3f-488d-9f6a-964c6a610149)

## Related Officers

- [Susan F. Laska](https://www.keypedia.com/people/susan-f-laska/27617a16-a7c0-4782-ab95-89c269832600)
- [Microbiologist](https://www.keypedia.com/people/camerson-e-moore/50733244-0d55-4b0b-a758-f192b7c66457)
- [sharon.thoma@fda.gov](https://www.keypedia.com/people/sharon-k-thoma/d72ee980-45a4-4f2c-9b1e-e29798492e7d)

Company: https://www.keypedia.com/companies/new-england-home-therapies-inc/3b7ab8b1-3850-4a33-8fc1-fe1453c67f73

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