Chongqing Biocare Pharmaceutical Ltd.
Form 483 issued September 22, 2023 · Chongqing, China
- Inspection
- Sep 18 – Sep 22, 2023
- Investigator
- Djamila Harouaka
- Observations
- 3
- Pages
- 2
- FEI number
- 3006305268
In short: On September 22, 2023, FDA issued a Form 483 with 3 observations to Chongqing Biocare Pharmaceutical Ltd. in Chongqing, China (FEI 3006305268) after an inspection that ran Sep 18 – Sep 22, 2023. The investigator was Djamila Harouaka. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.58 (maintenance).
At a glance
3 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.58 (2×) · 211.42 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
In the Grade D…
- 02
In the laboratory used to manufacture Intermediates 2 for OB in Workshop ©® the tape used…
- 03
The device used to discharge static electricity came loose and several bolts came off the wall…
This inspection in context
Djamila Harouaka
15 documents · 2015–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmChongqing Biocare Pharmaceutical Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.58
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Chongqing Biocare Pharmaceutical Ltd.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.58 (maintenance). The opening words of each observation are shown on this page.
Who inspected Chongqing Biocare Pharmaceutical Ltd.?
Djamila Harouaka is named on this Form 483, for the inspection of Sep 18 – Sep 22, 2023. Each investigator has a profile showing what they cite most.
When was Chongqing Biocare Pharmaceutical Ltd. inspected by FDA?
The inspection ran Sep 18 – Sep 22, 2023, and the Form 483 is dated September 22, 2023.
How do I get the full Form 483 for Chongqing Biocare Pharmaceutical Ltd.?
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