# FDA 483 - Liberty Drug & Surgical - May 22, 2015

Source: https://www.keypedia.com/records/483/liberty-drug-surgical/8a7a06be-aa00-4a13-ad58-9415287f3465

> FDA 483 for Liberty Drug & Surgical on May 22, 2015. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Liberty Drug & Surgical
- Inspection Date: 2015-05-22
- Product Type: Drugs
- Office Name: New Jersey District Office
- Summary: The FDA Form 483 details numerous deficiencies observed during an inspection of a drug manufacturing facility. The facility's design and operations are not preventing contamination. Raw materials, including non-sterile IV bags and containers, are handled in an uncontrolled pharmacy area, wiped with non-sterile materials, and transferred into ISO 7 and ISO 6 clean rooms without adequate sanitization. A non-sterile swab was used on IV bag ports in an ISO 5 laminar flow hood.

Procedures to prevent microbiological contamination are not established or followed; for instance, an IV bag that fell on the floor was still used for a patient prescription. The ISO 7 Anteroom is undersized and contains a sink with a non-potable water source.

Aseptic processing areas lack proper systems for maintaining equipment and monitoring environmental conditions. Smoke studies are not performed under dynamic conditions. Routine environmental monitoring (viable air, non-viable air, surface contact plates) is not conducted, with an outside lab performing it only quarterly. Viable and non-viable air monitoring is absent in the ISO 5 laminar flow hood, and personnel fingertip monitoring is not routine.

Personnel gowning is inappropriate, consisting of non-sterile lab coats, and sterile glove donning was observed to compromise sterility. Cleaning and disinfecting procedures are deficient, with non-sterile wipes stored improperly.

The stability program is inadequate; beyond-use dates for Doxycycline and 17-Hydroxyprogesterone were established without

## Related Officers

- [Senior Compliance Officer](https://www.keypedia.com/people/barbara-wilimczyk-macri/36eda42e-09b6-4364-a000-c5cd8ddb70ee)
- [Microbiologist](https://www.keypedia.com/people/susan-t-hadman/512c3274-4da8-4f5a-a081-965ab5ec84e6)
- [Advisor](https://www.keypedia.com/people/frederick-razzaghi/7346f6ec-1d9a-4ad3-abde-0497dcd9c8b5)
- [Equity Research Director](https://www.keypedia.com/people/philip-i-stefanos/82f37b9f-e2ac-4a39-b05c-da98454df190)
- [Director, Enterprise Regulatory Compliance](https://www.keypedia.com/people/nicholas-a-violand/c0c3ee7a-8adb-43d2-974c-06220ef8e8eb)

Company: https://www.keypedia.com/companies/liberty-drug-surgical/012f5cf3-b8cc-4861-b2bc-7090e1fac55d

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248