Mericon Industries, Inc.
Form 483 issued February 14, 2025 · Peoria, Illinois
- Investigators
- Justin A. Boyd· Lori B. Wikstrom
- Observations
- 8
- Pages
- 17
- FEI number
- 1450054
In short: On February 14, 2025, FDA issued a Form 483 with 8 observations to Mericon Industries, Inc. in Peoria, Illinois (FEI 1450054). The investigators were Justin A. Boyd and Lori B. Wikstrom. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and laboratory controls account for 5 of 8 observations.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to establish and follow written procedures for investigating critical deviations or the failure of API…
- 02
Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting…
- 03
Failure to demonstrate that your cleaning process can adequately clean the equipment, including utensils, used in…
- 04
Failure to ensure that all specifications and test procedures are scientifically sound and appropriate to ensure…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmMericon Industries, 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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Mericon Industries, Inc.?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. 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 Mericon Industries, Inc.?
Justin A. Boyd and Lori B. Wikstrom are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Mericon Industries, Inc. inspected by FDA?
This Form 483 is dated February 14, 2025.
How do I get the full Form 483 for Mericon Industries, 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.