# FDA 483 - ImmuCell Corporation - March 29, 2022

Source: https://www.keypedia.com/records/483/immucell-corporation/09c3698f-7f54-4eb4-84ab-ffb686e9e3db

> FDA 483 for ImmuCell Corporation on March 29, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ImmuCell Corporation
- Inspection Date: 2022-03-29
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: ImmuCell Corporation in Portland, ME, an Active Pharmaceutical Ingredient Manufacturer, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate qualification of manufacturing rooms and equipment, a systemic failure of the Quality Unit to document and investigate deviations, and a lack of proper supplier qualification for critical materials. These issues indicate a broad lack of control over manufacturing processes and quality assurance for Nisin Drug Substance and Re-TainTM finished drug product.

## Related Officers

- [investigator](https://www.keypedia.com/people/lauren-n-barber/31610942-583f-4d3d-b870-077aead3e16f)
- [Annet R. Rajan](https://www.keypedia.com/people/annet-r-rajan/81b5a458-094f-48a5-839d-5c47b1a7c259)
- [Director of Clinical Training](https://www.keypedia.com/people/helen-verdel/f6caf5a8-74f5-4833-bd00-5579b369f4f9)

Company: https://www.keypedia.com/companies/immucell-corporation/98fa3e35-5012-4248-bde8-768dbad0cac8

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94