FDA Intel

Nanchang Anobri Pharmaceutical CO., LTD Building B1, No. 888, Jingkai Avenue

Form 483 issued November 21, 2023 · Nanchang, China

Inspection
Nov 13 – Nov 21, 2023
Investigators
Dennis Cantellops Paite· Janete F. Guardia
Observations
12
Pages
8
FEI number
3023765884

In short: On November 21, 2023, FDA issued a Form 483 with 12 observations to Nanchang Anobri Pharmaceutical CO., LTD Building B1, No. 888, Jingkai Avenue in Nanchang, Jiangxi (FEI 3023765884) after an inspection that ran Nov 13 – Nov 21, 2023. The investigators were Dennis Cantellops Paite and Janete F. Guardia. Most observations concern laboratory controls and design controls; the most-cited regulation is 21 CFR 211.160 (general requirements).

At a glance

Observations span 4 systems, led by laboratory controls.

Laboratory controls2
Design controls2
Management controls2
Quality system1
Other5

Most cited: 21 CFR 211.160 (2×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01
    21 CFR 211.22(d)

    The responsibilities and procedures applicable to the quality control unit…

  2. 02
    21 CFR 211.160

    Established test procedures and laboratory control…

  3. 03
    21 CFR 211.160

    Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…

  4. 04
    21 CFR 211.80(b)

    There was a failure to handle and store components at all times in a…

8 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Dennis Cantellops Paite

2 documents · 2015–2023

Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in China.

The firm

Nanchang 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 483s

Other sites cited under 211.160

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 12 observations on this Form 483, mostly about laboratory controls, design controls and management controls. The most-cited regulation is 21 CFR 211.160 (general requirements). 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 Paite 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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