Linhai Tianyu Pharmaceutical Co., Ltd.
Form 483 issued September 15, 2023 · Taizhou, China
- Investigators
- Arsen Karapetyan· Sebreverse Cl Arsen Karapetyan
- Observations
- 7
- Pages
- 9
- FEI number
- 3013345425
In short: On September 15, 2023, FDA issued a Form 483 with 7 observations to Linhai Tianyu Pharmaceutical Co., Ltd. in Taizhou, Zhejiang (FEI 3013345425). The investigators were Arsen Karapetyan and Sebreverse Cl Arsen Karapetyan. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 5 of 7 observations.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are deficient for the cleaning and maintenance of equipment used in the manufacturing, processing…
- 02
Facilities and equipment used in the manufacturing of drug substances…
- 03
Written records of investigation into unexplained discrepancies and the failure of a batch or any of…
- 04
Laboratory records are not completed contemporaneously and do not include complete data derived from all tests…
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 firmLinhai Tianyu Pharmaceutical Co., Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Linhai Tianyu Pharmaceutical Co., Ltd.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Linhai Tianyu Pharmaceutical Co., Ltd.?
Arsen Karapetyan and Sebreverse Cl Arsen Karapetyan are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Linhai Tianyu Pharmaceutical Co., Ltd. inspected by FDA?
This Form 483 is dated September 15, 2023.
How do I get the full Form 483 for Linhai Tianyu 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.