Qilu Pharmaceutical (Hainan) Co., Ltd.
Form 483 issued November 6, 2019 · Haikou, China
- Inspection
- Oct 29 – Nov 6, 2019
- Investigator
- Joel D. Hustedt
- Observations
- 5
- Pages
- 4
- FEI number
- 3008250362
In short: On November 6, 2019, FDA issued a Form 483 with 5 observations to Qilu Pharmaceutical (Hainan) Co., Ltd. in Haikou, Hainan (FEI 3008250362) after an inspection that ran Oct 29 – Nov 6, 2019. The investigator was Joel D. Hustedt. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
3 of 5 observations on this 483 concern production.
Most cited: 21 CFR 211.110 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not followed that describe the examinations to be conducted on appropriate samples of…
- 02
Written records are not made of…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Joel D. Hustedt
25 documents · 2009–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in China.
The firmQilu Pharmaceutical (Hainan) Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Qilu Pharmaceutical (Hainan) Co., Ltd.?
FDA listed 5 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Qilu Pharmaceutical (Hainan) Co., Ltd.?
Joel D. Hustedt is named on this Form 483, for the inspection of Oct 29 – Nov 6, 2019. Each investigator has a profile showing what they cite most.
When was Qilu Pharmaceutical (Hainan) Co., Ltd. inspected by FDA?
The inspection ran Oct 29 – Nov 6, 2019, and the Form 483 is dated November 6, 2019.
How do I get the full Form 483 for Qilu Pharmaceutical (Hainan) 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.