# FDA 483 - Acella Pharmaceuticals, LLC - February 10, 2023

Source: https://www.globalkeysolutions.net/records/483/acella-pharmaceuticals-llc/a47ff318-a2b1-4547-8be6-ff4e3ddff1b5

> FDA 483 for Acella Pharmaceuticals, LLC on February 10, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Acella Pharmaceuticals, LLC
- Inspection Date: 2023-02-10
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Acella Pharmaceuticals, LLC, an Own Label Distributor in Alpharetta, GA, was cited with four observations, including repeat findings, during an FDA inspection. The firm demonstrated significant deficiencies in its quality control unit's responsibilities for drug product release and validation, inadequate laboratory controls for stability testing, and failures in thoroughly investigating discrepancies and handling product complaints. These issues indicate a lack of adherence to good manufacturing practices for drug products.

## Related Documents

- [EIR - 2017-03-08](https://www.globalkeysolutions.net/records/eir/acella-pharmaceuticals-llc/9c7922da-4f15-489d-93be-82bbb6994aca)
- [EIR - 2019-03-29](https://www.globalkeysolutions.net/records/eir/acella-pharmaceuticals-llc/cb1f9e55-2e6c-4e53-a434-cb3b36203f29)
- [483 - 2024-12-18](https://www.globalkeysolutions.net/records/483/acella-pharmaceuticals-llc/7c5ae9dd-2945-4d76-8669-e2a1fbcf43b3)
- [483 - 2021-09-17](https://www.globalkeysolutions.net/records/483/acella-pharmaceuticals-llc/b7225615-5386-4ced-8ce5-2efa60c37d5e)
- [WARNING_LETTER - 2020-01-07](https://www.globalkeysolutions.net/records/warning_letter/acella-pharmaceuticals-llc/65e0ddf5-ebd7-4a30-9f88-ce5bdb9a6402)

## Related Officers

- [Senior Manager, Executive Secretariat ](https://www.globalkeysolutions.net/people/jessica-m-simpson/94c06709-45cf-464f-92b4-ad3601ea20ab)
- [Pharmaceutical Specialist/ Investigator ](https://www.globalkeysolutions.net/people/veronica-fuentes/50ea657f-39e6-4d97-a627-86339df3fbe6)

Company: https://www.globalkeysolutions.net/companies/acella-pharmaceuticals-llc/95727716-8bc6-4b45-8f0b-2c018ea7f296

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