Taixing SynTheAll Pharmaceutical Co., Ltd
Form 483 issued September 27, 2024 · Taixing, China
- Investigators
- Angela E. Glenn· Michael A. Charles· Youkeun Kim
- Observations
- 5
- Pages
- 12
- FEI number
- 3025039932
In short: On September 27, 2024, FDA issued a Form 483 with 5 observations to Taixing SynTheAll Pharmaceutical Co., Ltd in Taixing, Jiangsu (FEI 3025039932). The investigators were Angela E. Glenn, Michael A. Charles and Youkeun Kim. Most observations concern materials and laboratory controls; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Observations span 4 systems, led by materials.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Raw material suppliers have not been qualified with all appropriate written specifications for…
- 02
Method validation program has not been established and documented for accuracy, sensitivity, specificity…
- 03
Your firm doesn't have an established Cleaning Validation program for manufacturing equipment to prevent contamination that…
- 04
Failure of quality unit to exercise its responsibility to ensure that…
This inspection in context
Angela E. Glenn
10 documents · 2016–2024
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmTaixing SynTheAll Pharmaceutical Co., Ltd history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Taixing SynTheAll Pharmaceutical Co., Ltd?
FDA listed 5 observations on this Form 483, mostly about materials, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Taixing SynTheAll Pharmaceutical Co., Ltd?
Angela E. Glenn, Michael A. Charles and Youkeun Kim are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Taixing SynTheAll Pharmaceutical Co., Ltd inspected by FDA?
This Form 483 is dated September 27, 2024.
How do I get the full Form 483 for Taixing SynTheAll Pharmaceutical Co., Ltd?
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