Hamari Pfst, Ltd.
Form 483 issued November 10, 2023 · Hachimampara, Japan
- Inspection
- Nov 6 – Nov 10, 2023
- Investigator
- Michele Gottshall
- Observations
- 2
- Pages
- 1
- FEI number
- 3002808528
In short: On November 10, 2023, FDA issued a Form 483 with 2 observations to Hamari Pfst, Ltd. in Hachimampara, Yamagata (FEI 3002808528) after an inspection that ran Nov 6 – Nov 10, 2023. The investigator was Michele Gottshall. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 1 system, led by facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not established for cleaning equipment and its subsequent release for use in…
- 02
When entries are made in records; these should be made directly…
This inspection in context
Michele Gottshall
12 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmHamari Pfst, Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hamari Pfst, Ltd.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Hamari Pfst, Ltd.?
Michele Gottshall is named on this Form 483, for the inspection of Nov 6 – Nov 10, 2023. Each investigator has a profile showing what they cite most.
When was Hamari Pfst, Ltd. inspected by FDA?
The inspection ran Nov 6 – Nov 10, 2023, and the Form 483 is dated November 10, 2023.
How do I get the full Form 483 for Hamari Pfst, Ltd.?
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.