# FDA 483 - Abbott's Compounding Pharmacy, Inc. - January 08, 2016

Source: https://www.keypedia.com/records/483/abbotts-compounding-pharmacy-inc/f0bc5b93-92ce-430e-afa8-b500dedfc192

> FDA 483 for Abbott's Compounding Pharmacy, Inc. on January 08, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abbott's Compounding Pharmacy, Inc.
- Inspection Date: 2016-01-08
- Product Type: Drugs
- Office Name: San Francisco District Office
- Summary: The FDA Form 483 details multiple deficiencies at a drug manufacturing facility. The clean room, where ISO 5 laminar air flow workbenches (LAFW) are located, is not maintained in a good state of repair, with detached Velcro seals on walls, a scratched wooden LAFW surface, wooden cabinets, and a hole in the wall.

Aseptic processing areas lack adequate air supply and environmental monitoring. Smoke studies in dynamic conditions for ISO 5 LAFW and ISO 7 clean rooms are not documented (e.g., video), and positive pressure airflow is not constant, with the air handling system observed turned off. There is no procedure for restarting the air handling system. Environmental monitoring for non-viable particulates, viable air, and surface monitoring is performed every six months, not daily. Personnel monitoring of operators' gloves is also performed every six months, not daily.

Protective apparel worn by sterile drug technicians is inadequate, consisting of non-sterile shoe covers, hair nets, face masks, lab coats, and sterile gloves. Technicians were observed without eye protection, and non-sterile masks did not provide adequate coverage, exposing forehead, face, and neck.

Procedures to prevent microbiological contamination are not established or followed. Technicians were observed moving components into the ISO 5 LAFW without disinfection, and only the bottoms of vials were wiped with a non-sterile cloth. The same non-sterile cloth was used for cleaning the LAFW before and after sterile

## Related Officers

- [Ashar Parikh Investigator](https://www.keypedia.com/people/ashar-parikh-investigator/0bc5966b-270b-4ad3-9ad9-9919fd7b0003)

Company: https://www.keypedia.com/companies/abbotts-compounding-pharmacy-inc/50e12bf3-51ad-4e6a-9365-5db1e56dc5b6

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df