Universal Packaging Systems Inc. DBA Pak
Form 483 issued November 30, 2017 · Batavia, Ohio
- Inspection
- Nov 27 – Nov 30, 2017
- Investigator
- Ucheabuchi C. Chudi-Nwankwor
- Observations
- 8
- Pages
- 5
- FEI number
- 1527626
In short: On November 30, 2017, FDA issued a Form 483 with 8 observations to Universal Packaging Systems Inc. DBA Pak in Batavia, Ohio (FEI 1527626) after an inspection that ran Nov 27 – Nov 30, 2017. The investigator was Ucheabuchi C. Chudi-Nwankwor. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
Quality system and production account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Procedures for the preparation of master production and control records are not described…
- 03
The batch production and control records are deficient in that they do not include documentation of…
- 04
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
This inspection in context
Ucheabuchi C. Chudi-Nwankwor
22 documents · 2016–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Ohio.
The firmUniversal Packaging Systems Inc. DBA Pak history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Universal Packaging Systems Inc. DBA Pak?
FDA listed 8 observations on this Form 483, mostly about quality system, production and materials. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Universal Packaging Systems Inc. DBA Pak?
Ucheabuchi C. Chudi-Nwankwor is named on this Form 483, for the inspection of Nov 27 – Nov 30, 2017. Each investigator has a profile showing what they cite most.
When was Universal Packaging Systems Inc. DBA Pak inspected by FDA?
The inspection ran Nov 27 – Nov 30, 2017, and the Form 483 is dated November 30, 2017.
How do I get the full Form 483 for Universal Packaging Systems Inc. DBA Pak?
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