# FDA 483 - Acella Pharmaceuticals, LLC - September 17, 2021

Source: https://www.globalkeysolutions.net/records/483/acella-pharmaceuticals-llc/b7225615-5386-4ced-8ce5-2efa60c37d5e

> FDA 483 for Acella Pharmaceuticals, LLC on September 17, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Acella Pharmaceuticals, LLC
- Inspection Date: 2021-09-17
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Acella Pharmaceuticals, LLC in Alpharetta, GA, revealed significant deficiencies across its quality management system. The firm failed to ensure proper quality control unit responsibilities, thoroughly investigate product discrepancies, adhere to complaint handling procedures, ensure qualified personnel, and follow written production and process control procedures. These issues led to the release of out-of-specification products and a systemic breakdown in quality assurance.

## 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)
- [WARNING_LETTER - 2020-01-07](https://www.globalkeysolutions.net/records/warning_letter/acella-pharmaceuticals-llc/65e0ddf5-ebd7-4a30-9f88-ce5bdb9a6402)
- [483 - 2019-03-29](https://www.globalkeysolutions.net/records/483/acella-pharmaceuticals-llc/701617cb-61e5-4e67-a13b-84fc6fd5151b)

## Related Officers

- [Strategic Communications Specialist, Consumer Safety Officer](https://www.globalkeysolutions.net/people/lavalais-song/ea936f12-0c09-43db-895c-24bb2efa5a90)
- [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