Evive Biopharmaceutical (Beijing), Ltd.
Form 483 issued June 7, 2023 · Beijing, China
- Inspection
- May 30 – Jun 7, 2023
- Observations
- 7
- Pages
- 3
- FEI number
- 3013430082
In short: On June 7, 2023, FDA issued a Form 483 with 7 observations to Evive Biopharmaceutical (Beijing), Ltd. in Beijing, China (FEI 3013430082) after an inspection that ran May 30 – Jun 7, 2023. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 6 of 7 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for microbial contamination…
- 02
Environmental monitoring program is inadequate. No batch-related dynamic environmental monitoring is performed during the batch manufacturing…
- 03
Procedures for cleanroom behavior…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Questions about this 483
What did FDA find at Evive Biopharmaceutical (Beijing), Ltd.?
FDA listed 7 observations on this Form 483, mostly about production, facilities & equipment and quality system. 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 Evive Biopharmaceutical (Beijing), Ltd. inspected by FDA?
The inspection ran May 30 – Jun 7, 2023, and the Form 483 is dated June 7, 2023.
How do I get the full Form 483 for Evive Biopharmaceutical (Beijing), 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.