ADIMMUNE CORPORATION
Form 483 issued July 30, 2018 · Taichung City, Taiwan
- Inspection
- Jul 19 – Jul 30, 2018
- Investigator
- Cynthia Jim
- Observations
- 14
- Pages
- 8
- FEI number
- 3008919998
In short: On July 30, 2018, FDA issued a Form 483 with 14 observations to ADIMMUNE CORPORATION in Taichung City, Taiwan (FEI 3008919998) after an inspection that ran Jul 19 – Jul 30, 2018. The investigator was Cynthia Jim. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.113 (3×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Media simulation studies are…
- 02
Drug product production and control records are not reviewed by the Quality Control Unit to determine…
- 03
Procedures designed for preventing microbial contamination of drug product purporting to be sterile do not include…
- 04
Monovalent drug substance lots manufactured from previous campaigns are stored in…
This inspection in context
Cynthia Jim
20 documents · 2012–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in North Carolina.
The firmADIMMUNE CORPORATION 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 ADIMMUNE CORPORATION?
FDA listed 14 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected ADIMMUNE CORPORATION?
Cynthia Jim is named on this Form 483, for the inspection of Jul 19 – Jul 30, 2018. Each investigator has a profile showing what they cite most.
When was ADIMMUNE CORPORATION inspected by FDA?
The inspection ran Jul 19 – Jul 30, 2018, and the Form 483 is dated July 30, 2018.
How do I get the full Form 483 for ADIMMUNE CORPORATION?
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.