# FDA 483 - Loop Plaza Pharmacy Company DBA Loop Compounding Pharmacy - September 25, 2018

Source: https://www.keypedia.com/records/483/loop-plaza-pharmacy-company-dba-loop-compounding-pharmacy/b6e52571-a039-4e36-8f59-7c15eb2ad608

> FDA 483 for Loop Plaza Pharmacy Company DBA Loop Compounding Pharmacy on September 25, 2018. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Loop Plaza Pharmacy Company DBA Loop Compounding Pharmacy
- Inspection Date: 2018-09-25
- Office Name: Baltimore District Office
- Summary: On September 19-21 and 24-25, 2018, the FDA inspected Loop Plaza Pharmacy Company DBA Loop Compounding Phar, located at 72 6th Ave, Saint Albans, WV. The firm is a producer of sterile and non-sterile drug products. The inspection revealed four observations.

Observation 1 noted that the ISO 5 classified area is within a non-classified room, lacking assurance of classified conditions for the cleanroom surrounding the ISO 5 laminar air flow hood. The last certification was on February 22, 2018, and was overdue for re-certification, with approximately 200 products produced since September.

Observation 2 identified the use of non-sterilized or non-depyrogenated tools or temporary containers in sterile drug production, specifically for storing bulk solutions. This raises concerns about sterility maintenance for products like Bupivacaine HCl 40mg/ml, Hydromorphone 100mg/ml, Morphine 100mg/ml, and Clonidine HCl 2000 mcg/ml, which are used for patient-specific prescriptions.

Observation 3, a repeat observation from a previous inspection, stated that ISO-5 classified areas were not certified under dynamic conditions. Specifically, no dynamic smoke studies were performed during the February 22, 2018 cleanroom certification to verify unidirectional airflow in the

## Related Documents

- [WARNING_LETTER - 2016-12-16](https://www.keypedia.com/records/warning_letter/loop-plaza-pharmacy-company-dba-loop-compounding-pharmacy/e286f1e6-c562-4986-ab39-494162fd1c27)
- [483 - 2018-09-25](https://www.keypedia.com/records/483/loop-plaza-pharmacy-company-dba-loop-compounding-pharmacy/b14de416-a9e6-401f-84e1-be6018f691f3)
- [483 - 2016-12-16](https://www.keypedia.com/records/483/loop-plaza-pharmacy-company-dba-loop-compounding-pharmacy/696411fc-667f-4523-85a8-b639a3930c32)

## Related Officers

- [Regulatory Counsel at FDA with a PharmD and JD](https://www.keypedia.com/people/melissa-t-roy/4aa8cad9-af71-45fd-a2c9-326a06f754c9)

Company: https://www.keypedia.com/companies/loop-plaza-pharmacy-company-dba-loop-compounding-pharmacy/0d7aab25-7237-48d8-bff0-f4bcd08bbfeb

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa