Shandong Xinhua Pharmaceutical Company Limited Hutian Branch
Form 483 issued March 29, 2019 · Zibo, China
- Inspection
- Mar 25 – Mar 29, 2019
- Investigator
- Arsen Karapetyan
- Observations
- 4
- Pages
- 12
- FEI number
- 3004254526
In short: On March 29, 2019, FDA issued a Form 483 with 4 observations to Shandong Xinhua Pharmaceutical Company Limited Hutian Branch in Zibo, Shandong (FEI 3004254526) after an inspection that ran Mar 25 – Mar 29, 2019. The investigator was Arsen Karapetyan. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
3 of 4 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (3×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 02
Batch production and control records for each batch of drug product produced do not include an…
- 03
Corrective and Preventive Actions and GMP relevant changes are not drafted by…
- 04
The responsibilities and procedures applicable to the quality unit are not in…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmShandong Xinhua Pharmaceutical Company Limited Hutian Branch history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Shandong Xinhua Pharmaceutical Company Limited Hutian Branch?
FDA listed 4 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Shandong Xinhua Pharmaceutical Company Limited Hutian Branch?
Arsen Karapetyan is named on this Form 483, for the inspection of Mar 25 – Mar 29, 2019. Each investigator has a profile showing what they cite most.
When was Shandong Xinhua Pharmaceutical Company Limited Hutian Branch inspected by FDA?
The inspection ran Mar 25 – Mar 29, 2019, and the Form 483 is dated March 29, 2019.
How do I get the full Form 483 for Shandong Xinhua Pharmaceutical Company Limited Hutian Branch?
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