Nanchang Anobri Pharmaceutical CO., LTD Building B1, No. 888, Jingkai Avenue
Form 483 issued November 21, 2023 · Nanchang City, China
- Inspection
- Nov 13 – Nov 21, 2023
- Investigators
- Dennis Cantellops· Janete F. Guardia
- Observations
- 2
- Pages
- 8
- FEI number
- 3023765884
In short: On November 21, 2023, FDA issued a Form 483 with 2 observations to Nanchang Anobri Pharmaceutical CO., LTD Building B1, No. 888, Jingkai Avenue in Nanchang City, China (FEI 3023765884) after an inspection that ran Nov 13 – Nov 21, 2023. The investigators were Dennis Cantellops and Janete F. Guardia. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.22(d) (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(Quality System) The responsibilities and procedures applicable to the quality control unit…
- 02
(Laboratory Control System) Established test procedures and laboratory control…
This inspection in context
Dennis Cantellops
10 documents · 2015–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmNanchang Anobri Pharmaceutical CO., LTD Building B1, No. 888, Jingkai Avenue history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nanchang Anobri Pharmaceutical CO., LTD Building B1, No. 888, Jingkai Avenue?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Nanchang Anobri Pharmaceutical CO., LTD Building B1, No. 888, Jingkai Avenue?
Dennis Cantellops and Janete F. Guardia are named on this Form 483, for the inspection of Nov 13 – Nov 21, 2023. Each investigator has a profile showing what they cite most.
When was Nanchang Anobri Pharmaceutical CO., LTD Building B1, No. 888, Jingkai Avenue inspected by FDA?
The inspection ran Nov 13 – Nov 21, 2023, and the Form 483 is dated November 21, 2023.
How do I get the full Form 483 for Nanchang Anobri Pharmaceutical CO., LTD Building B1, No. 888, Jingkai Avenue?
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