# FDA 483 - Queens Express Pharmacy - July 11, 2016

Source: https://www.keypedia.com/records/483/queens-express-pharmacy/50545a5c-6162-4bec-aee4-8f4266f3b57a

> FDA 483 for Queens Express Pharmacy on July 11, 2016. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Queens Express Pharmacy
- Inspection Date: 2016-07-11
- Product Type: Drugs
- Office Name: New York District Office
- Summary: During an inspection, the FDA observed five deficiencies at the firm.

**Observation 1:** Aseptic processing areas lacked a sufficient system for monitoring environmental conditions. Viable surface sampling using [(b) (4)] was conducted [(b) (4)] and not consistently on cleanroom operation days. Residual media from sampling could be left on LAF surfaces, requiring cleaning, but no written instructions existed for this.

**Observation 2:** Procedures to prevent microbiological contamination of sterile drug products were not established. Personnel monitoring was limited to fingertip sampling with [(b) (4)]. Drug product vials and diluent bags were transferred, [(b) (4)] with a [(b) (4)], and wiped with sterile [(b) (4)], but no contact time was established for this wiping.

**Observation 3:** Personnel clothing was inappropriate. Gloves available for cleanroom personnel were from a manufacturer previously removed from the approved list due to tearing issues. Management stated they had run out of the replacement gloves.

**Observation 4:** Aseptic processing areas were deficient in maintaining equipment for aseptic conditions. A smoke study video was found to [(b) (4)] and was not conducted under dynamic conditions representative of actual operations, including the maximum number of employees. The LAF in the video contained no other materials, but actual operations showed a technician working closely with the LAF operator [(b) (4)].

**Observation 5:** Drug products were not stored under appropriate

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Company: https://www.keypedia.com/companies/queens-express-pharmacy/c55c4287-06b5-4c48-9b55-3ed30dbf2138

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d