Hydrox Laboratories
Form 483 issued June 24, 2021 · Elgin, Illinois
- Inspection
- May 24 – Jun 24, 2021
- Investigator
- Kevin P. Regan
- Observations
- 9
- Pages
- 11
- FEI number
- 1419821
In short: On June 24, 2021, FDA issued a Form 483 with 9 observations to Hydrox Laboratories in Elgin, Illinois (FEI 1419821) after an inspection that ran May 24 – Jun 24, 2021. The investigator was Kevin P. Regan. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and production account for 7 of 9 observations.
Most cited: 21 CFR 211.67 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile…
- 02
There shall be appropriate laboratory testing, as necessary, of each batch of drug product required to…
- 03
Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils, used…
- 04
Equipment and utensils shall be cleaned, maintained, and, as appropriate for the nature of the drug…
This inspection in context
Kevin P. Regan
7 documents · 2021–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Minnesota.
The firmHydrox Laboratories history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hydrox Laboratories?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Hydrox Laboratories?
Kevin P. Regan is named on this Form 483, for the inspection of May 24 – Jun 24, 2021. Each investigator has a profile showing what they cite most.
When was Hydrox Laboratories inspected by FDA?
The inspection ran May 24 – Jun 24, 2021, and the Form 483 is dated June 24, 2021.
How do I get the full Form 483 for Hydrox Laboratories?
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.