Shandong New Time Pharmaceutical Co., Ltd.
Form 483 issued July 9, 2024 · Linyi, China
- Inspection
- Jul 1 – Jul 9, 2024
- Observations
- 2
- Pages
- 3
- FEI number
- 3006704412
In short: On July 9, 2024, FDA issued a Form 483 with 2 observations to Shandong New Time Pharmaceutical Co., Ltd. in Linyi, Shandong (FEI 3006704412) after an inspection that ran Jul 1 – Jul 9, 2024. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×) · 211.110 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established…
- 02
Procedures are not established to monitor the output and validate the performance of manufacturing processes that…
This inspection in context
Questions about this 483
What did FDA find at Shandong New Time Pharmaceutical Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
When was Shandong New Time Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Jul 1 – Jul 9, 2024, and the Form 483 is dated July 9, 2024.
How do I get the full Form 483 for Shandong New Time Pharmaceutical Co., Ltd.?
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