Celeste Industries Corporation
Form 483 issued February 28, 2025 · Easton, Maryland
- Inspection
- Feb 26 – Feb 28, 2025
- Investigator
- John D. McIntosh
- Observations
- 7
- Pages
- 7
- FEI number
- 3012532308
In short: On February 28, 2025, FDA issued a Form 483 with 7 observations to Celeste Industries Corporation in Easton, Maryland (FEI 3012532308) after an inspection that ran Feb 26 – Feb 28, 2025. The investigator was John D. McIntosh. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
The accuracy, sensitivity, specificity and reproducibility of test methods…
- 02
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the education…
- 03
The establishment of laboratory control mechanisms including any changes thereto, are not drafted by…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
John D. McIntosh
3 documents · 2024–2026
Cites 211.100(a) (written procedures; deviations) more than any other section. Most of their documents are for sites in Maryland.
The firmCeleste Industries Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Celeste Industries Corporation?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Celeste Industries Corporation?
John D. McIntosh is named on this Form 483, for the inspection of Feb 26 – Feb 28, 2025. Each investigator has a profile showing what they cite most.
When was Celeste Industries Corporation inspected by FDA?
The inspection ran Feb 26 – Feb 28, 2025, and the Form 483 is dated February 28, 2025.
How do I get the full Form 483 for Celeste Industries Corporation?
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.