Hisamitsu Pharmaceutical Co., Inc.
Form 483 issued May 31, 2019 · Tosu, Japan
- Inspection
- May 27 – May 31, 2019
- Investigators
- Caroline Strasinger· Saundrea A. Munroe
- Observations
- 4
- Pages
- 3
- FEI number
- 1000266995
In short: On May 31, 2019, FDA issued a Form 483 with 4 observations to Hisamitsu Pharmaceutical Co., Inc. in Tosu, Saga (FEI 1000266995) after an inspection that ran May 27 – May 31, 2019. The investigators were Caroline Strasinger and Saundrea A. Munroe. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
3 of 4 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165 (2×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drug products failing to meet established specifications and quality control…
- 02
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Caroline Strasinger
1 document · 2019
Cites 211.165 (testing and release for distribution) more than any other section. Most of their documents are for sites in Japan.
The firmHisamitsu Pharmaceutical Co., Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hisamitsu Pharmaceutical Co., Inc.?
FDA listed 4 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Hisamitsu Pharmaceutical Co., Inc.?
Caroline Strasinger and Saundrea A. Munroe are named on this Form 483, for the inspection of May 27 – May 31, 2019. Each investigator has a profile showing what they cite most.
When was Hisamitsu Pharmaceutical Co., Inc. inspected by FDA?
The inspection ran May 27 – May 31, 2019, and the Form 483 is dated May 31, 2019.
How do I get the full Form 483 for Hisamitsu Pharmaceutical Co., Inc.?
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.