Pyramid Laboratories, Inc.
Form 483 issued January 15, 2015 · Costa Mesa, California
- Inspection
- Jan 5 – Jan 15, 2015
- Investigators
- Caryn M. McNab· Jennifer M. Gogley
- Observations
- 13
- Pages
- 6
- FEI number
- 1000160734
In short: On January 15, 2015, FDA issued a Form 483 with 13 observations to Pyramid Laboratories, Inc. in Costa Mesa, California (FEI 1000160734) after an inspection that ran Jan 5 – Jan 15, 2015. The investigators were Caryn M. McNab and Jennifer M. Gogley. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 8 of 13 observations.
Most cited: 21 CFR 211.22 (2×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records are not always made of…
- 02
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
- 03
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 04
The quality control unit lacks authority to fully investigate…
This inspection in context
Caryn M. McNab
7 documents · 2013–2023
Cites 211.42 (design and construction features) 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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pyramid Laboratories, Inc.?
FDA listed 13 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Pyramid Laboratories, Inc.?
Caryn M. McNab and Jennifer M. Gogley are named on this Form 483, for the inspection of Jan 5 – Jan 15, 2015. Each investigator has a profile showing what they cite most.
When was Pyramid Laboratories, Inc. inspected by FDA?
The inspection ran Jan 5 – Jan 15, 2015, and the Form 483 is dated January 15, 2015.
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.