Infinity Laboratories LLC
Form 483 issued January 7, 2021 · Castle Rock, Colorado
- Inspection
- Jan 5 – Jan 7, 2021
- Investigator
- Michael A. Charles
- Observations
- 4
- Pages
- 4
- FEI number
- 1000517789
In short: On January 7, 2021, FDA issued a Form 483 with 4 observations to Infinity Laboratories LLC in Castle Rock, Colorado (FEI 1000517789) after an inspection that ran Jan 5 – Jan 7, 2021. The investigator was Michael A. Charles. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
3 of 4 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into unexplained discrepancies do not always include…
- 02
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 03
Determinations of conformance to appropriate written specifications for acceptance are not…
- 04
The calibration of instruments is not done at suitable intervals in accordance with…
This inspection in context
Michael A. Charles
29 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
The firmInfinity Laboratories LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Infinity Laboratories LLC?
FDA listed 4 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Infinity Laboratories LLC?
Michael A. Charles is named on this Form 483, for the inspection of Jan 5 – Jan 7, 2021. Each investigator has a profile showing what they cite most.
When was Infinity Laboratories LLC inspected by FDA?
The inspection ran Jan 5 – Jan 7, 2021, and the Form 483 is dated January 7, 2021.
How do I get the full Form 483 for Infinity Laboratories LLC?
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.