LFB USA, Inc.
Form 483 issued April 8, 2022 · Charlton, Massachusetts
- Investigator
- Laurel A. Beer
- Observations
- 11
- Pages
- 5
- FEI number
- 3013501870
In short: On April 8, 2022, FDA issued a Form 483 with 11 observations to LFB USA, Inc. in Charlton, Massachusetts (FEI 3013501870). The investigator was Laurel A. Beer. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.113 (3×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The Sevenfact intermediate is not being manufactured in…
- 02
There is a failure to demonstrate that the quality of water is suitable for its intended…
- 03
The (B)(4) rabbit milk (source material) bioburden specifications used in the manufacture of Sevenfact intermediate is…
- 04
An initial stability OOS result for protein concentration was not included in the annual stability data…
This inspection in context
Laurel A. Beer
14 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in North Carolina.
The firmLFB USA, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LFB USA, Inc.?
FDA listed 11 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected LFB USA, Inc.?
Laurel A. Beer is named on this Form 483. Each investigator has a profile showing what they cite most.
When was LFB USA, Inc. inspected by FDA?
This Form 483 is dated April 8, 2022.
How do I get the full Form 483 for LFB USA, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.