Green Wave Analytical, LLC
Form 483 issued March 7, 2022 · San Diego, California
- Inspection
- Feb 15 – Mar 7, 2022
- Investigators
- Claudia M. Perez-Kasmarski· Lisa Shin
- Observations
- 7
- Pages
- 7
- FEI number
- 3016367069
In short: On March 7, 2022, FDA issued a Form 483 with 7 observations to Green Wave Analytical, LLC in San Diego, California (FEI 3016367069) after an inspection that ran Feb 15 – Mar 7, 2022. The investigators were Claudia M. Perez-Kasmarski and Lisa Shin. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
6 of 7 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194 (4×) · 211.160 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no quality…
- 02
The establishment of specifications, standards, sampling plans, test procedures and laboratory control mechanisms including any changes…
- 03
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…
- 04
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
This inspection in context
Claudia M. Perez-Kasmarski
11 documents · 2020–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmGreen Wave Analytical, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Green Wave Analytical, LLC?
FDA listed 7 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Green Wave Analytical, LLC?
Claudia M. Perez-Kasmarski and Lisa Shin are named on this Form 483, for the inspection of Feb 15 – Mar 7, 2022. Each investigator has a profile showing what they cite most.
When was Green Wave Analytical, LLC inspected by FDA?
The inspection ran Feb 15 – Mar 7, 2022, and the Form 483 is dated March 7, 2022.
How do I get the full Form 483 for Green Wave Analytical, 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.