Qilu Animal Health Products Co., Ltd.
Form 483 issued July 26, 2024 · Jinan, China
- Inspection
- Jul 17 – Jul 26, 2024
- Investigators
- Es Kevin Rice· Laura S. Hufiiman
- Observations
- 7
- Pages
- 8
- FEI number
- 3011568807
In short: On July 26, 2024, FDA issued a Form 483 with 7 observations to Qilu Animal Health Products Co., Ltd. in Jinan, Shandong (FEI 3011568807) after an inspection that ran Jul 17 – Jul 26, 2024. The investigators were Es Kevin Rice and Laura S. Hufiiman. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 6 of 7 observations.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
(b) ()processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 03
Aseptic processing area are deficient regarding the system…
- 04
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
This inspection in context
Es Kevin Rice
1 document · 2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in China.
The firmQilu Animal Health Products Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Qilu Animal Health Products Co., Ltd.?
FDA listed 7 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Qilu Animal Health Products Co., Ltd.?
Es Kevin Rice and Laura S. Hufiiman are named on this Form 483, for the inspection of Jul 17 – Jul 26, 2024. Each investigator has a profile showing what they cite most.
When was Qilu Animal Health Products Co., Ltd. inspected by FDA?
The inspection ran Jul 17 – Jul 26, 2024, and the Form 483 is dated July 26, 2024.
How do I get the full Form 483 for Qilu Animal Health Products 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.