# FDA 483 - Park Avenue Compounding - August 28, 2019

Source: https://www.keypedia.com/records/483/park-avenue-compounding/e5836937-07e7-4934-bc06-786b12c877ca

> FDA 483 for Park Avenue Compounding on August 28, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Park Avenue Compounding
- Inspection Date: 2019-08-28
- Product Type: Drugs
- Office Name: Kansas City District Office
- Summary: The FDA Form 483 details multiple deficiencies at a facility producing sterile drug products, including Total Parenteral Nutrition (TPN) and patient-specific prescriptions.

**Microbiological Contamination Prevention:** Procedures are not established or followed. Operators contacted cleanroom and anteroom surfaces with gloved and ungloved hands. Smoke studies for ISO 5 hoods were not representative of TPN production, conducted in empty hoods with basic manipulations. A trash can lid blocked airflow in an ISO 5 hood, potentially causing turbulent airflow. Media fills simulating TPN production have not been conducted.

**Environmental Monitoring:** The system for monitoring aseptic processing areas is deficient. Viable and nonviable environmental sampling is not routinely performed in classified rooms or hoods during patient-specific product production. Cleanroom door handles, anteroom door handles, and computer keyboards, frequently touched, are not included in the environmental monitoring program. Personnel monitoring lacks an appropriate schedule for operator gloves and gowns during or after aseptic operations. Large doors between the ISO 7 anteroom and unclassified area are not interlocked, allowing both to open simultaneously.

**Quality Control and Release:** Acceptance criteria for sampling and testing are inadequate. The product inspection process is deficient, with 100% visual checks against a contrasting background not always performed for sterile drug preparations and repackaged products prior to release. Examples include Norepinephrine Bitartrate (22% inspected), Oxytocin (25% inspected), Phenylephrine HCl (25%

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## Related Officers

- [Mindy M. Chou](https://www.keypedia.com/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)

Company: https://www.keypedia.com/companies/park-avenue-compounding/796f839f-10c0-4749-bac4-0c226419c3d1

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79