# FDA 483 - Loop Plaza Pharmacy Company DBA Loop Compounding Pharmacy - December 16, 2016

Source: https://www.keypedia.com/records/483/loop-plaza-pharmacy-company-dba-loop-compounding-pharmacy/696411fc-667f-4523-85a8-b639a3930c32

> FDA 483 for Loop Plaza Pharmacy Company DBA Loop Compounding Pharmacy on December 16, 2016. Product: Drugs. 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: 2016-12-16
- Product Type: Drugs
- Office Name: Baltimore District Office
- Summary: The FDA Form 483 details multiple deficiencies observed during an inspection of a facility producing aseptically filled drug products.

**Facility and Operations:** The facility produces sterile injectable products, including Glycerin 98.5 Ophthalmic and intrathecal pain pump refills (morphine, hydrocodone, bupivacaine, baclofen). Operations involve ISO 5 laminar air flow benches, ISO 7, and ISO 8 rooms.

**Violations and Observations:**

*   **Aseptic Processing Area Deficiencies:**
    *   Cleaning of ISO 7, ISO 8 rooms, and ISO 5 benches lacks a sporicidal agent.
    *   Drug spills in ISO 5 benches are cleaned with a previously used sterile spray bottle.
    *   No data confirms adequate removal of smoke study residue from ISO 5 hoods.
    *   Four dead bugs were found within a light fixture in the ISO 7 room.
    *   Environmental monitoring in aseptic processing areas is deficient.
*   **Stability Testing Program Deficiencies:**
    *   No written stability testing program exists.
    *   Insufficient test data supports Beyond Use Dates (BUDs) for injectable products, including Glycerin 98.5 Ophthalmic (1-month refrigerated BUD).
    *   No potency, sterility, or endotoxin data supports container closure systems for intrathecal pain pump refills stored in a freezer with multiple removals

## 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/b6e52571-a039-4e36-8f59-7c15eb2ad608)
- [483 - 2018-09-25](https://www.keypedia.com/records/483/loop-plaza-pharmacy-company-dba-loop-compounding-pharmacy/b14de416-a9e6-401f-84e1-be6018f691f3)

## Related Officers

- [ Investigator ](https://www.keypedia.com/people/matthew-b-casale/e78481c6-5fbd-4723-a79c-167176395af8)

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