Hisamitsu Pharmaceutical Co., Inc.
Form 483 issued October 11, 2019 · Utsunomiya, Japan
- Inspection
- Oct 7 – Oct 11, 2019
- Investigator
- Pratik S. Upadhyay
- Observations
- 5
- Pages
- 9
- FEI number
- 3008742780
In short: On October 11, 2019, FDA issued a Form 483 with 5 observations to Hisamitsu Pharmaceutical Co., Inc. in Utsunomiya, Tochigi (FEI 3008742780) after an inspection that ran Oct 7 – Oct 11, 2019. The investigator was Pratik S. Upadhyay. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 3 of 5 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Written records are not made of investigations into unexplained discrepancies and the failure of a batch…
- 03
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 04
Deviations from written production and process control procedures are…
This inspection in context
Pratik S. Upadhyay
48 documents · 2011–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmHisamitsu Pharmaceutical Co., Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hisamitsu Pharmaceutical Co., Inc.?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Hisamitsu Pharmaceutical Co., Inc.?
Pratik S. Upadhyay is named on this Form 483, for the inspection of Oct 7 – Oct 11, 2019. Each investigator has a profile showing what they cite most.
When was Hisamitsu Pharmaceutical Co., Inc. inspected by FDA?
The inspection ran Oct 7 – Oct 11, 2019, and the Form 483 is dated October 11, 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.