Otsuka Pharmaceutical Co., Ltd.
Form 483 issued April 15, 2016 · Tokushima, Japan
- Inspection
- Apr 11 – Apr 15, 2016
- Investigator
- Saleem A. Akhtar
- Observations
- 5
- Pages
- 4
- FEI number
- 3002809299
In short: On April 15, 2016, FDA issued a Form 483 with 5 observations to Otsuka Pharmaceutical Co., Ltd. in Tokushima, Japan (FEI 3002809299) after an inspection that ran Apr 11 – Apr 15, 2016. The investigator was Saleem A. Akhtar. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
5 of 5 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×) · 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 02
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the…
This inspection in context
Saleem A. Akhtar
35 documents · 2004–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmOtsuka Pharmaceutical Co., 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 Otsuka Pharmaceutical Co., Ltd.?
FDA listed 5 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 Otsuka Pharmaceutical Co., Ltd.?
Saleem A. Akhtar is named on this Form 483, for the inspection of Apr 11 – Apr 15, 2016. Each investigator has a profile showing what they cite most.
When was Otsuka Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Apr 11 – Apr 15, 2016, and the Form 483 is dated April 15, 2016.
How do I get the full Form 483 for Otsuka 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.