Skytronics Ltd, Inc.
Form 483 issued January 12, 2026 · Burbank, California
- Inspection
- Jan 6 – Jan 12, 2026
- Investigator
- Bryan L. McGuckin
- Observations
- 6
- Pages
- 6
- FEI number
- 3012259838
In short: On January 12, 2026, FDA issued a Form 483 with 6 observations to Skytronics Ltd, Inc. in Burbank, California (FEI 3012259838) after an inspection that ran Jan 6 – Jan 12, 2026. The investigator was Bryan L. McGuckin. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
Written procedures are not reviewed and approved by the quality…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 06
Written procedures for cleaning and maintenance fail to include assignment of responsibility, maintenance and cleaning schedules…
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 firmSkytronics Ltd, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Skytronics Ltd, Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Skytronics Ltd, Inc.?
Bryan L. McGuckin is named on this Form 483, for the inspection of Jan 6 – Jan 12, 2026. Each investigator has a profile showing what they cite most.
When was Skytronics Ltd, Inc. inspected by FDA?
The inspection ran Jan 6 – Jan 12, 2026, and the Form 483 is dated January 12, 2026.
How do I get the full Form 483 for Skytronics Ltd, 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.