Collaborative Laboratory Services, LLC- Saint Francis Campus
Form 483 issued August 20, 2025 · Connecticut
- Inspection
- Aug 19 – Aug 20, 2025
- Investigator
- Victoria V. Bot
- Observations
- 1
- Pages
- 2
- FEI number
- 1270168
In short: On August 20, 2025, FDA issued a Form 483 with 1 observation to Collaborative Laboratory Services, LLC- Saint Francis Campus in Connecticut (FEI 1270168) after an inspection that ran Aug 19 – Aug 20, 2025. The investigator was Victoria V. Bot. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.151 (compatibility testing).
At a glance
1 of 1 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 606.151(e) (1×)
What FDA observed
Preview: the opening words of each observation- 0121 CFR 606.151(e)
Records including signature by the physician requesting the procedure are not maintained…
This inspection in context
Victoria V. Bot
1 document · 2025
Cites 606.151(e) (compatibility testing) more than any other section. Most of their documents are for sites in Connecticut.
The firmCollaborative Laboratory Services, LLC- Saint Francis Campus history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Collaborative Laboratory Services, LLC- Saint Francis Campus?
FDA listed 1 observation on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.151 (compatibility testing). The opening words of each observation are shown on this page.
Who inspected Collaborative Laboratory Services, LLC- Saint Francis Campus?
Victoria V. Bot is named on this Form 483, for the inspection of Aug 19 – Aug 20, 2025. Each investigator has a profile showing what they cite most.
When was Collaborative Laboratory Services, LLC- Saint Francis Campus inspected by FDA?
The inspection ran Aug 19 – Aug 20, 2025, and the Form 483 is dated August 20, 2025.
How do I get the full Form 483 for Collaborative Laboratory Services, LLC- Saint Francis Campus?
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.