Agilent Technologies, Inc.
Form 483 issued August 2, 2019 · Boulder, Colorado
- Inspection
- Jul 29 – Aug 2, 2019
- Observations
- 3
- Pages
- 3
- FEI number
- 3007057070
In short: On August 2, 2019, FDA issued a Form 483 with 3 observations to Agilent Technologies, Inc. in Boulder, Colorado (FEI 3007057070) after an inspection that ran Jul 29 – Aug 2, 2019. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 3 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory investigations are incomplete and do…
- 02
Your procedure for investigating laboratory nonconformances and…
- 03
Procedures designed to prevent objectionable microorganisms in the API drug substance not required to be…
This inspection in context
Questions about this 483
What did FDA find at Agilent Technologies, Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Agilent Technologies, Inc. inspected by FDA?
The inspection ran Jul 29 – Aug 2, 2019, and the Form 483 is dated August 2, 2019.
How do I get the full Form 483 for Agilent Technologies, 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.