# FDA 483 - Park Avenue Compounding - February 08, 2024

Source: https://www.keypedia.com/records/483/park-avenue-compounding/989b7159-5889-459d-bc4f-040c205faf6a

> FDA 483 for Park Avenue Compounding on February 08, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Park Avenue Compounding
- Inspection Date: 2024-02-08
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 details ten observations from an inspection of an outsourcing facility.

**Facility and Operations:** The facility compounds various drug products, including Morphine Sulfate, Fentanyl, Ropivacaine, and penicillin/beta-lactam products.

**Violations and Observations:**

1.  **Production and Process Controls:** Failure to establish written procedures for production and process controls. Two potency failures for Morphine Sulfate 50 mg in 50 mL of NS (1 mg/mL) were observed (206.5% and 76.0%). Interim CAPA was ineffective, and new batch steps were undocumented. Process validation for Morphine Sulfate was not performed.
2.  **Aseptic Processing Area Monitoring:** Deficient environmental monitoring. Active viable monitoring is only performed after production, with questionable device placement. Non-Viable Particle (NVP) monitoring locations are inconsistent. Settle plate placement was observed to be directly behind a spray bottle, potentially inhibiting microbial growth. Surface sampling is limited to one area. Production technician monitoring lacks scientific justification for frequency and acceptance limits, with some samples held to ISO 7 standards instead of ISO 5.
3.  **Penicillin Processing:** Operations for penicillin and beta-lactam products were performed in the same hood used for other drug products, with numerous instances documented in 2022 and 2023.
4.  **Expiration Dating:** Stability

## Related Documents

- [WARNING_LETTER - 2014-08-14](https://www.keypedia.com/records/warning_letter/park-avenue-compounding/edb33a9b-862c-4aaf-b7f6-12edd372e8a8)
- [483 - 2025-09-11](https://www.keypedia.com/records/483/park-avenue-compounding/21e271fe-445d-4416-872a-cedadf5b2f26)
- [483 - 2017-11-16](https://www.keypedia.com/records/483/park-avenue-compounding/f0f45ca6-1747-44c2-a00b-1ceafd26537e)
- [483 - 2021-09-28](https://www.keypedia.com/records/483/park-avenue-compounding/72fc9eaf-dd8b-4eca-b546-5e46a8ead0fe)
- [483 - 2014-08-14](https://www.keypedia.com/records/483/park-avenue-compounding/2b7a9390-73c4-4ff5-b451-ed0924e4df35)

## Related Officers

- [Consumer Safety Officer/ Federal Investigator](https://www.keypedia.com/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)
- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)

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

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c