# FDA 483 - Acella Pharmaceuticals, LLC - March 29, 2019

Source: https://www.keypedia.com/records/483/acella-pharmaceuticals-llc/701617cb-61e5-4e67-a13b-84fc6fd5151b

> FDA 483 for Acella Pharmaceuticals, LLC on March 29, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Acella Pharmaceuticals, LLC
- Inspection Date: 2019-03-29
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Acella Pharmaceuticals, Llc in Alpharetta, GA, from March 25-29, 2019, revealed two significant issues related to regulatory reporting. The firm failed to submit annual reports for an approved drug product within the required 60-day timeframe. Additionally, not all annual Periodic Adverse Drug Experience Reports (PADERs) for multiple approved drug products were submitted within 60 days of their respective anniversary dates.

## Related Documents

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

## Related Officers

- [Vanessa E. Coulter](https://www.keypedia.com/people/vanessa-e-coulter/add8407c-0df8-43ed-9f5a-8063880ce638)

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

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