FDA 483 - Marlborough Hospital - September 17, 2014

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