Pyramid Laboratories, Inc.
Amended 483 issued February 13, 2026 · Costa Mesa, California
- Inspection
- Feb 2 – Feb 13, 2026
- Investigators
- Ana-Maria A. Plapcianu· Aranjeet Singh· Bryan A. Galvez
- Observations
- 2
- Pages
- 4
- FEI number
- 1000160734
In short: On February 13, 2026, FDA issued a Amended 483 with 2 observations to Pyramid Laboratories, Inc. in Costa Mesa, California (FEI 1000160734) after an inspection that ran Feb 2 – Feb 13, 2026. The investigators were Ana-Maria A. Plapcianu, Aranjeet Singh, Bryan A. Galvez, Cecilia H. Kieu, Joan M. Cantellops Figueroa, Navneet Kaur and Sangeeta M. Khurana. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.65 (equipment construction).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.65(a) (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment surf;ices that contact components and in-prc>cess mate•rials are reactive, additive or absorptive so as to…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
The full amended 483
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Ana-Maria A. Plapcianu
4 documents · 2020–2026
Cites 211.67 (equipment cleaning and maintenance) 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 documentsOther sites cited under 211.65(a)
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Pyramid Laboratories, Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.65 (equipment construction). The opening words of each observation are shown on this page.
Who inspected Pyramid Laboratories, Inc.?
Ana-Maria A. Plapcianu, Aranjeet Singh, Bryan A. Galvez, Cecilia H. Kieu, Joan M. Cantellops Figueroa, Navneet Kaur and Sangeeta M. Khurana are named on this Amended 483, for the inspection of Feb 2 – Feb 13, 2026. Each investigator has a profile showing what they cite most.
When was Pyramid Laboratories, Inc. inspected by FDA?
The inspection ran Feb 2 – Feb 13, 2026, and the Amended 483 is dated February 13, 2026.
How do I get the full Amended 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.