Bell International Laboratories, Inc
Form 483 issued September 19, 2023 · Eagan, Minnesota
- Inspection
- Sep 11 – Sep 19, 2023
- Observations
- 10
- Pages
- 9
- FEI number
- 3005574978
In short: On September 19, 2023, FDA issued a Form 483 with 10 observations to Bell International Laboratories, Inc in Eagan, Minnesota (FEI 3005574978) after an inspection that ran Sep 11 – Sep 19, 2023. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Quality system and materials account for 6 of 10 observations.
Most cited: 21 CFR 211.84 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks the responsibility and authority to approve and reject all components, drug…
- 02
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
- 03
Complaint procedures are deficient in that they do not include provisions that allow for the review…
- 04
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
This inspection in context
Questions about this 483
What did FDA find at Bell International Laboratories, Inc?
FDA listed 10 observations on this Form 483, mostly about quality system, materials and production. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
When was Bell International Laboratories, Inc inspected by FDA?
The inspection ran Sep 11 – Sep 19, 2023, and the Form 483 is dated September 19, 2023.
How do I get the full Form 483 for Bell International Laboratories, Inc?
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