Pyramid Laboratories, Inc.
Form 483 issued April 11, 2019 · Costa Mesa, California
- Inspection
- Apr 1 – Apr 11, 2019
- Investigators
- Amanda L. Fyles· Christopher R. Czajka· Jolanna A. Norton
- Observations
- 1
- Pages
- 3
- FEI number
- 1000160734
In short: On April 11, 2019, FDA issued a Form 483 with 1 observation to Pyramid Laboratories, Inc. in Costa Mesa, California (FEI 1000160734) after an inspection that ran Apr 1 – Apr 11, 2019. The investigators were Amanda L. Fyles, Christopher R. Czajka and Jolanna A. Norton. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Amanda L. Fyles
5 documents · 2017–2019
Cites 211.165 (testing and release for distribution) more than any other section. Most of their documents are for sites in California.
The firmPyramid Laboratories, Inc. history
All 5 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 Pyramid Laboratories, Inc.?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Pyramid Laboratories, Inc.?
Amanda L. Fyles, Christopher R. Czajka and Jolanna A. Norton are named on this Form 483, for the inspection of Apr 1 – Apr 11, 2019. Each investigator has a profile showing what they cite most.
When was Pyramid Laboratories, Inc. inspected by FDA?
The inspection ran Apr 1 – Apr 11, 2019, and the Form 483 is dated April 11, 2019.
How do I get the full Form 483 for Pyramid 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.