# FDA 483 - LFB USA, Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/lfb-usa-inc/d5cb42c1-4c7a-4485-a0e4-2c96bbb1b239

> FDA 483 for LFB USA, Inc. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LFB USA, Inc.
- Product Type: biologics
- Office Name: Division of Northeast Imports 
- Summary: LFB USA Inc., a biologics manufacturer in Charlton, MA, was cited for significant quality control deficiencies during an FDA inspection. Observations included uninvestigated mold contamination in Sevenfact intermediate manufacturing, inadequate water quality, and insufficient bioburden specifications. The firm also failed in data integrity, document control, stability data reporting, and equipment qualification.

## Related Officers

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Company: https://www.keypedia.com/companies/lfb-usa-inc/0ce33194-ad37-4a33-ac26-fb8a40ba3c7c

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