Guilin Pharmaceutical Co., Ltd
Form 483 issued March 13, 2015 · Guilin, China
- Inspection
- Mar 9 – Mar 13, 2015
- Investigator
- Steven D. Kehoe
- Observations
- 1
- Pages
- 1
- FEI number
- 3002807125
In short: On March 13, 2015, FDA issued a Form 483 with 1 observation to Guilin Pharmaceutical Co., Ltd in Guilin, China (FEI 3002807125) after an inspection that ran Mar 9 – Mar 13, 2015. The investigator was Steven D. Kehoe. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations into observed discrepancies do not always include corrective and preventive actions which fully address the…
This inspection in context
Steven D. Kehoe
4 documents · 2015–2016
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmGuilin Pharmaceutical Co., Ltd history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Guilin Pharmaceutical Co., Ltd?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Guilin Pharmaceutical Co., Ltd?
Steven D. Kehoe is named on this Form 483, for the inspection of Mar 9 – Mar 13, 2015. Each investigator has a profile showing what they cite most.
When was Guilin Pharmaceutical Co., Ltd inspected by FDA?
The inspection ran Mar 9 – Mar 13, 2015, and the Form 483 is dated March 13, 2015.
How do I get the full Form 483 for Guilin 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.