MicroBiopharm Japan Co., Ltd.
Form 483 issued September 13, 2019 · Iwata, Japan
- Inspection
- Sep 9 – Sep 13, 2019
- Investigator
- Cheryl Clausen
- Observations
- 5
- Pages
- 4
- FEI number
- 3003992082
In short: On September 13, 2019, FDA issued a Form 483 with 5 observations to MicroBiopharm Japan Co., Ltd. in Iwata, Shizuoka (FEI 3003992082) after an inspection that ran Sep 9 – Sep 13, 2019. The investigator was Cheryl Clausen. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and production account for 4 of 5 observations.
Most cited: 21 CFR 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
You do not always have adequate control over computerized systems to: prevent unauthorized access, prevent changes…
- 02
You do not always have adequate process controls to ensure harvest and purification procedures protect…
- 03
Your system for managing quality…
- 04
Batch production records do not include complete information relating to production and…
This inspection in context
Cheryl Clausen
18 documents · 2016–2020
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmMicroBiopharm Japan Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MicroBiopharm Japan Co., Ltd.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected MicroBiopharm Japan Co., Ltd.?
Cheryl Clausen is named on this Form 483, for the inspection of Sep 9 – Sep 13, 2019. Each investigator has a profile showing what they cite most.
When was MicroBiopharm Japan Co., Ltd. inspected by FDA?
The inspection ran Sep 9 – Sep 13, 2019, and the Form 483 is dated September 13, 2019.
How do I get the full Form 483 for MicroBiopharm Japan 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.