# FDA 483 - The Compounding Pharmacy - September 29, 2021

Source: https://www.keypedia.com/records/483/the-compounding-pharmacy/342ecb31-779e-459f-9dff-0bb651fdb1bd

> FDA 483 for The Compounding Pharmacy on September 29, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The Compounding Pharmacy
- Inspection Date: 2021-09-29
- Product Type: Drugs
- Office Name: Atlanta District Office
- Summary: The FDA Form 483 details observations from an inspection concerning facility design, equipment cleanliness, and sterilization processes.

**Facility and Operations:** The facility includes ISO 7 classified cleanrooms ((b)(4) and (b)(4)) where sterile products (intrathecal, intravitreal, intravenous, intramuscular) are compounded within close proximity (3-8 feet) of mini-split air conditioning (AC) units.

**Violations and Observations:**

1.  **Air Quality Compromise:**
    *   Mini-split AC units in ISO 7 cleanrooms, containing condensers and fans, are particle-generating equipment without HEPA filtration, potentially compromising the ISO 5 area.
    *   A hole for the AC unit's drain tube in cleanroom (b)(4) showed air movement from an unclassified space, indicating an unsealed connection.
    *   A gap between the AC unit in cleanroom (b)(4) and the wall suggests an unsealed connection.
    *   Stagnant water with black deposition and a white spot was observed in the drain tube on the unclassified side.
    *   AC unit vents are positioned to potentially blow directly into the ISO 5 aseptic processing area.

2.  **Difficult-to-Clean/Dirty Equipment/Surfaces:**
    *   AC units in cleanrooms (b)(4) and (b)(4) are surrounded by non-clean

## Related Documents

- [WARNING_LETTER - 2019-04-08](https://www.keypedia.com/records/warning_letter/the-compounding-pharmacy/8fc86eb5-fd7d-4745-a330-a943a84c632b)

## Related Officers

- [Commissioned Corps of the U.S. Public Health Service](https://www.keypedia.com/people/adam-r-cooke/337c005d-e9dc-4512-aadb-ee0b0c637bd5)

Company: https://www.keypedia.com/companies/the-compounding-pharmacy/d16766c1-e8e3-4409-bca7-7e831f0b1490

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7