Shenzhen Oriental Pharmaceutical Co. Ltd.
Form 483 issued January 11, 2019 · Shenzhen, China
- Inspection
- Jan 9, 2017 – Jan 11, 2019
- Investigator
- Matthew B. Casale
- Observations
- 4
- Pages
- 2
- FEI number
- 3003677845
In short: On January 11, 2019, FDA issued a Form 483 with 4 observations to Shenzhen Oriental Pharmaceutical Co. Ltd. in Shenzhen, China (FEI 3003677845) after an inspection that ran Jan 9, 2017 – Jan 11, 2019. The investigator was Matthew B. Casale. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 1 system, led by quality system.
Most cited: 21 CFR 211.192 (1×) · 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
Observation 1: scanned text, readable in the full document.
- 02
Bovh ot the Invesnigati ona/ Tesrag Pfotoce/ anel Aryorova | Sheers useol 16 approve and Wtou…
- 03
she 2617 Annval Padacr…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Matthew B. Casale
29 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
The firmShenzhen Oriental Pharmaceutical Co. Ltd. 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 Shenzhen Oriental Pharmaceutical Co. Ltd.?
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 Shenzhen Oriental Pharmaceutical Co. Ltd.?
Matthew B. Casale is named on this Form 483, for the inspection of Jan 9, 2017 – Jan 11, 2019. Each investigator has a profile showing what they cite most.
When was Shenzhen Oriental Pharmaceutical Co. Ltd. inspected by FDA?
The inspection ran Jan 9, 2017 – Jan 11, 2019, and the Form 483 is dated January 11, 2019.
How do I get the full Form 483 for Shenzhen Oriental Pharmaceutical Co. Ltd.?
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.