Laclede, Inc.
Form 483 issued November 7, 2018 · Rancho Dominguez, California
- Inspection
- Oct 9 – Nov 7, 2018
- Investigators
- Andrew K. Haack· Marcus F. Yambot
- Observations
- 8
- Pages
- 8
- FEI number
- 2022474
In short: On November 7, 2018, FDA issued a Form 483 with 8 observations to Laclede, Inc. in Rancho Dominguez, California (FEI 2022474) after an inspection that ran Oct 9 – Nov 7, 2018. The investigators were Andrew K. Haack and Marcus F. Yambot. Most observations concern design controls and laboratory controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and laboratory controls account for 5 of 8 observations.
Most cited: 21 CFR 820.30 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for design control…
- 02
Risk analysis was not…
- 03
The design history. file…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Andrew K. Haack
12 documents · 2017–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Washington.
The firmLaclede, 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 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Laclede, Inc.?
FDA listed 8 observations on this Form 483, mostly about design controls, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Laclede, Inc.?
Andrew K. Haack and Marcus F. Yambot are named on this Form 483, for the inspection of Oct 9 – Nov 7, 2018. Each investigator has a profile showing what they cite most.
When was Laclede, Inc. inspected by FDA?
The inspection ran Oct 9 – Nov 7, 2018, and the Form 483 is dated November 7, 2018.
How do I get the full Form 483 for Laclede, 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.