Pyramid Laboratories, Inc.
Form 483 issued September 29, 2021 · Costa Mesa, California
- Inspection
- Sep 20 – Sep 29, 2021
- Investigators
- Claudia M. Perez-Kasmarski· Miguel A. Martinez
- Observations
- 5
- Pages
- 6
- FEI number
- 1000160734
In short: On September 29, 2021, FDA issued a Form 483 with 5 observations to Pyramid Laboratories, Inc. in Costa Mesa, California (FEI 1000160734) after an inspection that ran Sep 20 – Sep 29, 2021. The investigators were Claudia M. Perez-Kasmarski and Miguel A. Martinez. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
3 of 5 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
In-process samples are not…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
The establishment of laboratory control mechanisms including any changes thereto, are not reviewed and approved by…
- 04
Laboratory records do not include complete records of the periodic…
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 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 211.160(b)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pyramid Laboratories, Inc.?
FDA listed 5 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Pyramid Laboratories, Inc.?
Claudia M. Perez-Kasmarski and Miguel A. Martinez are named on this Form 483, for the inspection of Sep 20 – Sep 29, 2021. Each investigator has a profile showing what they cite most.
When was Pyramid Laboratories, Inc. inspected by FDA?
The inspection ran Sep 20 – Sep 29, 2021, and the Form 483 is dated September 29, 2021.
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.