Nanjing King-Friend Biochemical Pharmaceutical Co.,Ltd. (FDF Site)
Form 483 issued April 3, 2018 · Nanjing, China
- Inspection
- Mar 26 – Apr 3, 2018
- Investigators
- Darren S. Brown· Djamila Harouaka· Orthis Pron Rose Xu
- Observations
- 4
- Pages
- 3
- FEI number
- 3010625707
In short: On April 3, 2018, FDA issued a Form 483 with 4 observations to Nanjing King-Friend Biochemical Pharmaceutical Co.,Ltd. (FDF Site) in Nanjing, Jiangsu (FEI 3010625707) after an inspection that ran Mar 26 – Apr 3, 2018. The investigators were Darren S. Brown, Djamila Harouaka, Orthis Pron Rose Xu and Rose Xu. 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 3 of 4 observations.
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 not established…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Darren S. Brown
27 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmNanjing King-Friend Biochemical Pharmaceutical Co.,Ltd. (FDF Site) history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nanjing King-Friend Biochemical Pharmaceutical Co.,Ltd. (FDF Site)?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and materials. 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 Nanjing King-Friend Biochemical Pharmaceutical Co.,Ltd. (FDF Site)?
Darren S. Brown, Djamila Harouaka, Orthis Pron Rose Xu and Rose Xu are named on this Form 483, for the inspection of Mar 26 – Apr 3, 2018. Each investigator has a profile showing what they cite most.
When was Nanjing King-Friend Biochemical Pharmaceutical Co.,Ltd. (FDF Site) inspected by FDA?
The inspection ran Mar 26 – Apr 3, 2018, and the Form 483 is dated April 3, 2018.
How do I get the full Form 483 for Nanjing King-Friend Biochemical Pharmaceutical Co.,Ltd. (FDF Site)?
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.