Gordon Laboratories, Inc.
Form 483 issued March 10, 2022 · Carson, California
- Inspection
- Feb 8 – Mar 10, 2022
- Investigators
- Gavin T. Cua· Joel D. Hustedt
- Observations
- 1
- Pages
- 9
- FEI number
- 2012546
In short: On March 10, 2022, FDA issued a Form 483 with 1 observation to Gordon Laboratories, Inc. in Carson, California (FEI 2012546) after an inspection that ran Feb 8 – Mar 10, 2022. The investigators were Gavin T. Cua and Joel D. Hustedt. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Gavin T. Cua
9 documents · 2022–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmGordon Laboratories, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Gordon Laboratories, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Gordon Laboratories, Inc.?
Gavin T. Cua and Joel D. Hustedt are named on this Form 483, for the inspection of Feb 8 – Mar 10, 2022. Each investigator has a profile showing what they cite most.
When was Gordon Laboratories, Inc. inspected by FDA?
The inspection ran Feb 8 – Mar 10, 2022, and the Form 483 is dated March 10, 2022.
How do I get the full Form 483 for Gordon 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.