Tianjin Asymchem Pharmaceuticals Co., Ltd.
Form 483 issued March 29, 2024 · Tianjin, China
- Inspection
- Mar 29, 2024
- Observations
- 2
- Pages
- 2
- FEI number
- 3013090624
In short: On March 29, 2024, FDA issued a Form 483 with 2 observations to Tianjin Asymchem Pharmaceuticals Co., Ltd. in Tianjin, Tianjin (FEI 3013090624) after an inspection that ran Mar 29, 2024. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.25 (1×) · 211.186 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The personnel are not properly trained in their particular job functions and records…
- 02
Batch production and control records do not include complete information relating to the production and…
This inspection in context
Questions about this 483
What did FDA find at Tianjin Asymchem Pharmaceuticals Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
When was Tianjin Asymchem Pharmaceuticals Co., Ltd. inspected by FDA?
The inspection ran Mar 29, 2024, and the Form 483 is dated March 29, 2024.
How do I get the full Form 483 for Tianjin Asymchem Pharmaceuticals 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.