Rohto Pharmaceutical Co., Ltd.
Form 483 issued March 8, 2023 · Iga, Japan
- Inspection
- Feb 27 – Mar 8, 2023
- Investigators
- Michael E. Maselli· Michele Perry Williams
- Observations
- 6
- Pages
- 6
- FEI number
- 3003722237
In short: On March 8, 2023, FDA issued a Form 483 with 6 observations to Rohto Pharmaceutical Co., Ltd. in Iga, Mie (FEI 3003722237) after an inspection that ran Feb 27 – Mar 8, 2023. The investigators were Michael E. Maselli and Michele Perry Williams. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 5 of 6 observations.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 03
Procedures describing the handling of all written and oral complaints regarding a drug product are…
- 04
Written procedures are not established for evaluations done at least annually and including provisions for a…
This inspection in context
Michael E. Maselli
6 documents · 2015–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Colorado.
The firmRohto Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Rohto Pharmaceutical Co., Ltd.?
FDA listed 6 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Rohto Pharmaceutical Co., Ltd.?
Michael E. Maselli and Michele Perry Williams are named on this Form 483, for the inspection of Feb 27 – Mar 8, 2023. Each investigator has a profile showing what they cite most.
When was Rohto Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Feb 27 – Mar 8, 2023, and the Form 483 is dated March 8, 2023.
How do I get the full Form 483 for Rohto Pharmaceutical Co., 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.