Sato Pharmaceutical Co., Ltd
Form 483 issued July 3, 2018 · Hachioji, Japan
- Inspection
- Jun 25 – Jul 3, 2018
- Investigator
- Lata Mathew
- Observations
- 4
- Pages
- 3
- FEI number
- 3004055563
In short: On July 3, 2018, FDA issued a Form 483 with 4 observations to Sato Pharmaceutical Co., Ltd in Hachioji, Tokyo (FEI 3004055563) after an inspection that ran Jun 25 – Jul 3, 2018. The investigator was Lata Mathew. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
A backup file of data entered into the computer or related systems is not maintained of…
This inspection in context
Lata Mathew
24 documents · 2017–2024
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmSato Pharmaceutical Co., Ltd history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sato Pharmaceutical Co., Ltd?
FDA listed 4 observations on this Form 483, mostly about quality system, production and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Sato Pharmaceutical Co., Ltd?
Lata Mathew is named on this Form 483, for the inspection of Jun 25 – Jul 3, 2018. Each investigator has a profile showing what they cite most.
When was Sato Pharmaceutical Co., Ltd inspected by FDA?
The inspection ran Jun 25 – Jul 3, 2018, and the Form 483 is dated July 3, 2018.
How do I get the full Form 483 for Sato 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.