Pyramid Laboratories, Inc.
Form 483 issued February 3, 2021 · Costa Mesa, California
- Inspection
- Jan 28 – Feb 3, 2021
- Investigator
- Michael R. Shanks
- Observations
- 1
- Pages
- 1
- FEI number
- 1000160734
In short: On February 3, 2021, FDA issued a Form 483 with 1 observation to Pyramid Laboratories, Inc. in Costa Mesa, California (FEI 1000160734) after an inspection that ran Jan 28 – Feb 3, 2021. The investigator was Michael R. Shanks. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Michael R. Shanks
27 documents · 2017–2024
Cites 211.113 (control of microbiological contamination) 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 211.113
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 production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Pyramid Laboratories, Inc.?
Michael R. Shanks is named on this Form 483, for the inspection of Jan 28 – Feb 3, 2021. Each investigator has a profile showing what they cite most.
When was Pyramid Laboratories, Inc. inspected by FDA?
The inspection ran Jan 28 – Feb 3, 2021, and the Form 483 is dated February 3, 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.