# FDA 483 - Marlborough Hospital - September 17, 2014

Source: https://www.keypedia.com/records/483/marlborough-hospital/5a85ec1d-a51d-46e2-a499-c9a421441c10

> FDA 483 for Marlborough Hospital on September 17, 2014. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Marlborough Hospital
- Inspection Date: 2014-09-17
- Product Type: Drugs
- Office Name: New England District Office
- Summary: This FDA Form 483 document outlines deficiencies observed during an inspection of a facility involved in aseptic processing of sterile drug products.

**Facility and Operation Details:** The facility utilizes ISO 5, ISO 7, and ISO 8 areas, including Biological Safety Cabinet (BSC) hoods, for aseptic manipulation and production of sterile drug products.

**Violations and Observations:**

1.  **Deficient Environmental Monitoring System:**
    *   **Observation A:** Environmental monitoring of the ISO 5 area and BSC hoods is performed by pharmacy staff. However, these staff members lack adequate training in microbiology and reading petri dish results.
    *   **Observation B:** Personnel monitoring of pharmacy staff is conducted, but the document does not specify deficiencies in this particular aspect beyond the training issue mentioned in A.

2.  **Deficient Equipment Maintenance for Aseptic Conditions:**
    *   The firm has not performed air flow pattern studies (smoke studies) in their ISO 5 hoods, ISO 7, and ISO 8 rooms under dynamic conditions, which are used for sterile drug product production.

3.  **Deficient Cleaning and Disinfecting System:**
    *   The firm's cleaning procedure for aseptic areas lacks the use of a sporicidal agent.

**Regulatory Citations and Requirements:** The observations indicate non-compliance with regulations pertaining to environmental monitoring, equipment qualification/maintenance, and cleaning/disinfection procedures in aseptic processing areas, which are

## Related Documents

- [STATE_REFERRAL_LETTER - 2014-09-08](https://www.keypedia.com/records/state_referral_letter/marlborough-hospital/a4397194-9c7f-4d06-920a-6c5e80b43843)

## Related Officers

- [Consumer safety officer](https://www.keypedia.com/people/mary-mcgarry/e18b8fd4-f2d0-4415-86b0-92f24198c1fa)

Company: https://www.keypedia.com/companies/marlborough-hospital/bf807868-a89c-4599-9a03-b79bb0a8a3ea

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