Life Technologies Corporation
Form 483 issued June 14, 2021 · Frederick, Maryland
- Inspection
- Jun 7 – Jun 14, 2021
- Investigator
- Jude C. Dike
- Observations
- 2
- Pages
- 4
- FEI number
- 3003335080
In short: On June 14, 2021, FDA issued a Form 483 with 2 observations to Life Technologies Corporation in Frederick, Maryland (FEI 3003335080) after an inspection that ran Jun 7 – Jun 14, 2021. The investigator was Jude C. Dike. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
CAPA and production & process controls account for 2 of 2 observations.
Most cited: 21 CFR 820.100(a) (1×) · 820.120(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Labeling was not sufficiently examined by a designated individual for accuracy including the correct…
This inspection in context
Jude C. Dike
9 documents · 2015–2022
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Maryland.
The firmLife Technologies Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Life Technologies Corporation?
FDA listed 2 observations on this Form 483, mostly about cAPA and production & process controls. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Life Technologies Corporation?
Jude C. Dike is named on this Form 483, for the inspection of Jun 7 – Jun 14, 2021. Each investigator has a profile showing what they cite most.
When was Life Technologies Corporation inspected by FDA?
The inspection ran Jun 7 – Jun 14, 2021, and the Form 483 is dated June 14, 2021.
How do I get the full Form 483 for Life Technologies Corporation?
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.