Qingdao BAHEAL Pharmaceutical Co.,Ltd.
Form 483 issued December 6, 2019 · Qingdao, China
- Inspection
- Dec 2 – Dec 6, 2019
- Investigator
- Joel D. Hustedt
- Observations
- 4
- Pages
- 3
- FEI number
- 3011922870
In short: On December 6, 2019, FDA issued a Form 483 with 4 observations to Qingdao BAHEAL Pharmaceutical Co.,Ltd. in Qingdao, Shandong (FEI 3011922870) after an inspection that ran Dec 2 – Dec 6, 2019. The investigator was Joel D. Hustedt. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
3 of 4 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 02
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods…
- 03
Batch production and control records do not include complete information relating to the production and…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Joel D. Hustedt
25 documents · 2009–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in China.
The firmQingdao BAHEAL Pharmaceutical Co.,Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Qingdao BAHEAL Pharmaceutical Co.,Ltd.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Qingdao BAHEAL Pharmaceutical Co.,Ltd.?
Joel D. Hustedt is named on this Form 483, for the inspection of Dec 2 – Dec 6, 2019. Each investigator has a profile showing what they cite most.
When was Qingdao BAHEAL Pharmaceutical Co.,Ltd. inspected by FDA?
The inspection ran Dec 2 – Dec 6, 2019, and the Form 483 is dated December 6, 2019.
How do I get the full Form 483 for Qingdao BAHEAL Pharmaceutical 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.