Paket Corporation

Form 483 issued August 6, 2019 · Chicago, Illinois

Inspection: Jul 19 – Aug 6, 2019
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. Most observations concern production and quality system.

At a glance

Production and quality system account for 3 of 5 observations.

Production2

Quality system1

Facilities & equipment1

Materials1

What FDA observed

Preview: the opening words of each observation

01
21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in…
02
21 CFR 211.67(b)
Written procedures for cleaning and maintenance fail to include assignment of responsibility, maintenance and cleaning schedules…
03
21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process…
04
21 CFR 211.150(b)
A system by which the distribution of each lot of drug product can be readily determined…

1 more observation

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The firm

Paket Corporation history

All 3 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other 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.

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.