Paket Corporation
Form 483 issued April 10, 2025 · Chicago, Illinois
- Inspection
- Apr 8 – Apr 10, 2025
- Investigators
- Daveta L. Bailey· Sonya M. Edmonds
- Observations
- 5
- Pages
- 23
- FEI number
- 1416209
In short: On April 10, 2025, FDA issued a Form 483 with 5 observations to Paket Corporation in Chicago, Illinois (FEI 1416209) after an inspection that ran Apr 8 – Apr 10, 2025. The investigators were Daveta L. Bailey and Sonya M. Edmonds. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies do not…
- 02
Aseptic processing areas are deficient in that floors are not smooth and/or hard surfaces…
- 03
Buildings used in the manufacturing of a drug product are not maintained in a good state…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and standards designed…
This inspection in context
Daveta L. Bailey
2 documents · 2017–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Illinois.
The firmPaket Corporation history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Paket Corporation?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Paket Corporation?
Daveta L. Bailey and Sonya M. Edmonds are named on this Form 483, for the inspection of Apr 8 – Apr 10, 2025. Each investigator has a profile showing what they cite most.
When was Paket Corporation inspected by FDA?
The inspection ran Apr 8 – Apr 10, 2025, and the Form 483 is dated April 10, 2025.
How do I get the full Form 483 for Paket 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.