Adamson Analytical Laboratories, Inc.
Form 483 issued March 23, 2021 · Corona, California
- Inspection
- Mar 8 – Mar 23, 2021
- Investigators
- Bryan A. Galvez· Walden H. Lee
- Observations
- 4
- Pages
- 10
- FEI number
- 3000204955
In short: On March 23, 2021, FDA issued a Form 483 with 4 observations to Adamson Analytical Laboratories, Inc. in Corona, California (FEI 3000204955) after an inspection that ran Mar 8 – Mar 23, 2021. The investigators were Bryan A. Galvez and Walden H. Lee. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Laboratory controls and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The accuracy; sensitivity, specificity and reproducibility of test methods have not…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
- 05
The establishment of specifications and test procedures including any changes thereto, are not drafted by the…
This inspection in context
Bryan A. Galvez
15 documents · 2018–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmAdamson Analytical Laboratories, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Adamson Analytical Laboratories, Inc.?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Adamson Analytical Laboratories, Inc.?
Bryan A. Galvez and Walden H. Lee are named on this Form 483, for the inspection of Mar 8 – Mar 23, 2021. Each investigator has a profile showing what they cite most.
When was Adamson Analytical Laboratories, Inc. inspected by FDA?
The inspection ran Mar 8 – Mar 23, 2021, and the Form 483 is dated March 23, 2021.
How do I get the full Form 483 for Adamson Analytical Laboratories, 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.