Innovatical Laboratories LLC
Form 483 issued January 16, 2026 · Montclair, California
- Inspection
- Jan 13 – Jan 16, 2026
- Investigators
- Bryan L. McGuckin· Devisree P. Mattigiri
- Observations
- 4
- Pages
- 6
- FEI number
- 3008918562
In short: On January 16, 2026, FDA issued a Form 483 with 4 observations to Innovatical Laboratories LLC in Montclair, California (FEI 3008918562) after an inspection that ran Jan 13 – Jan 16, 2026. The investigators were Bryan L. McGuckin and Devisree P. Mattigiri. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Input to and output from the computer and records or data are not checked…
- 02
The responsibilities and procedures applicable to the quality control unit are not in writing and fully…
- 04
Separate or defined areas to p revent contamination or mix-ups are deficient regarding laboratory controls…
- 05
GMP training is not conducted to assure that employees remain familiar with CGMP requirements applicable…
This inspection in context
Bryan L. McGuckin
30 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
The firmInnovatical Laboratories LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Innovatical Laboratories LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Innovatical Laboratories LLC?
Bryan L. McGuckin and Devisree P. Mattigiri are named on this Form 483, for the inspection of Jan 13 – Jan 16, 2026. Each investigator has a profile showing what they cite most.
When was Innovatical Laboratories LLC inspected by FDA?
The inspection ran Jan 13 – Jan 16, 2026, and the Form 483 is dated January 16, 2026.
How do I get the full Form 483 for Innovatical Laboratories LLC?
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.