Paket Corporation
Form 483 issued August 6, 2019 · Chicago, Illinois
- Inspection
- Jul 19 – Aug 6, 2019
- Investigator
- Brian D. Nicholson
- Observations
- 5
- Pages
- 6
- FEI number
- 1416209
In short: On August 6, 2019, FDA issued a Form 483 with 5 observations to Paket Corporation in Chicago, Illinois (FEI 1416209) after an inspection that ran Jul 19 – Aug 6, 2019. The investigator was Brian D. Nicholson. Most observations concern production and quality system.
At a glance
Production and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Written procedures for cleaning and maintenance fail to include assignment of responsibility, maintenance and cleaning schedules…
- 03
Written production and process control procedures are not followed in the execution of production and process…
- 04
A system by which the distribution of each lot of ding product can be readily determined…
This inspection in context
Brian D. Nicholson
20 documents · 2013–2022
Cites 211.113 (control of microbiological contamination) 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 211.22(d)
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 production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Paket Corporation?
Brian D. Nicholson is named on this Form 483, for the inspection of Jul 19 – Aug 6, 2019. Each investigator has a profile showing what they cite most.
When was Paket Corporation inspected by FDA?
The inspection ran Jul 19 – Aug 6, 2019, and the Form 483 is dated August 6, 2019.
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.