# FDA 483 - Epic Pharma, LLC - October 23, 2023

Source: https://www.globalkeysolutions.net/records/483/epic-pharma-llc/40f97d43-f9d1-4eb9-b459-afa53bf02c0c

> FDA 483 for Epic Pharma, LLC on October 23, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Epic Pharma, LLC
- Inspection Date: 2023-10-23
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Epic Pharma, LLC in Laurelton, NY, from October 16-23, 2023, identified significant deficiencies in the firm's equipment cleaning and maintenance procedures. The observations included inadequate cleaning validation for drug products and tablet presses, as well as a lack of established cleaning times and documentation in several standard operating procedures. These issues indicate a lack of control over cleaning processes, raising concerns about potential product contamination and reproducibility.

## Related Documents

- [EIR - 2019-02-01](https://www.globalkeysolutions.net/records/eir/epic-pharma-llc/1e895f54-a7eb-44c1-9cb2-14faf97f3237)
- [483 - 2019-02-01](https://www.globalkeysolutions.net/records/483/epic-pharma-llc/a5f59299-0cb4-4673-aade-4753d575ecd8)

## Related Officers

- [Evan Tong](https://www.globalkeysolutions.net/people/evan-tong/2cd81562-886c-4672-9522-a07fb1b33ef2)
- [Drug Investigator](https://www.globalkeysolutions.net/people/syeda-n-mahazabin/54af6f8a-6d41-4399-b58e-a2d88fd2d7bf)

Company: https://www.globalkeysolutions.net/companies/epic-pharma-llc/d5595bb3-7707-47d9-8994-5fad8148274b

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961