# FDA 483 - Alkermes Inc - October 19, 2023

Source: https://www.keypedia.com/records/483/alkermes-inc/95258bb8-236c-40b0-8ccb-1570c9ec1064

> FDA 483 for Alkermes Inc on October 19, 2023. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Alkermes Inc
- Inspection Date: 2023-10-19
- Product Type: Drugs
- Office Name: Cincinnati District Office
- Summary: This FDA Form 483 was issued to Alkermes Inc., a manufacturer located in Wilmington, OH, following an inspection from September 25 to October 19, 2023. The inspection revealed seven observations regarding the firm's manufacturing and quality control processes.

Observation 1 notes inadequate validation of sterile drug product processes, specifically in smoke studies where unidirectional airflow was not demonstrated due to improper probe positioning and camera angles.

Observation 2 highlights deficiencies in laboratory controls, including the lack of inspection and documentation for sterile gloves upon receipt, and the absence of appropriate procedures to qualify microbiologists for counting Colony Forming Units (CFU) on media plates.

Observation 3 indicates insufficient controls over computer systems, as audit trails or revision histories of the (b)(4) system used for drug product analysis are not reviewed by the quality unit to detect unauthorized changes.

Observation 4 details inadequate employee training. Supervising microbiologists overseeing environmental and personal monitoring, and water samples, lacked documented qualification for CFU counting. Additionally, the training procedure for microbial growth determination was deficient, lacking specifics on challenging CFU adequacy, counting methods, and visual aids.

Observation 5 states that the quality control unit's responsibilities and procedures are not fully followed. The change control procedure lacks predetermined criteria for post-implementation evaluation, and the firm failed to conduct or document effectiveness checks for ten reviewed change controls.

Observation 6 identifies an inadequate investigation into a quality-related complaint (PR

## Related Officers

- [Ucheabuchi C. Chudi-nwankwor](https://www.keypedia.com/people/ucheabuchi-c-chudi-nwankwor/18b01d08-3cfd-4ace-97b2-5f54b6427661)

Company: https://www.keypedia.com/companies/alkermes-inc/c20f3273-400d-4b2e-a485-214b986ed7c2

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22