CHANGZHOU RUIMING PHARMACEUTICAL CO LTD NO 1558 LONGJIANG BEI RD
Form 483 issued September 13, 2018 · CHANGZHOU, China
- Inspection
- Sep 10 – Sep 13, 2018
- Investigator
- Christopher T. Middendorf
- Observations
- 3
- Pages
- 2
- FEI number
- 007086821
In short: On September 13, 2018, FDA issued a Form 483 with 3 observations to CHANGZHOU RUIMING PHARMACEUTICAL CO LTD NO 1558 LONGJIANG BEI RD in CHANGZHOU, China (FEI 007086821) after an inspection that ran Sep 10 – Sep 13, 2018. The investigator was Christopher T. Middendorf. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
2 of 3 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Electronic records associated with QC testing of finished APIs are…
- 02
Procedures related to the review of…
- 03
Laboratory procedures are not…
This inspection in context
Christopher T. Middendorf
8 documents · 2011–2020
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in China.
The firmCHANGZHOU RUIMING PHARMACEUTICAL CO LTD NO 1558 LONGJIANG BEI RD history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CHANGZHOU RUIMING PHARMACEUTICAL CO LTD NO 1558 LONGJIANG BEI RD?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected CHANGZHOU RUIMING PHARMACEUTICAL CO LTD NO 1558 LONGJIANG BEI RD?
Christopher T. Middendorf is named on this Form 483, for the inspection of Sep 10 – Sep 13, 2018. Each investigator has a profile showing what they cite most.
When was CHANGZHOU RUIMING PHARMACEUTICAL CO LTD NO 1558 LONGJIANG BEI RD inspected by FDA?
The inspection ran Sep 10 – Sep 13, 2018, and the Form 483 is dated September 13, 2018.
How do I get the full Form 483 for CHANGZHOU RUIMING PHARMACEUTICAL CO LTD NO 1558 LONGJIANG BEI RD?
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.