Nantong Chanyoo Pharmatech Co., Ltd
Form 483 issued March 22, 2019 · Nantong, China
- Inspection
- Mar 19 – Mar 22, 2019
- Observations
- 4
- Pages
- 3
- FEI number
- 3011243688
In short: On March 22, 2019, FDA issued a Form 483 with 4 observations to Nantong Chanyoo Pharmatech Co., Ltd in Nantong, Jiangsu (FEI 3011243688) after an inspection that ran Mar 19 – Mar 22, 2019. Most observations concern facilities & equipment and materials; 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 maintenance and calibration activities do not include evaluation of all processing parameters which verify manufacturing…
- 02
Procedures should be established for the preventative maintenance of equipment which include the tasks…
- 03
Any building used in the manufacture, processing, packing or holding of a drug product shall be…
- 04
Your material system and inventory records do not maintain accurate information of each component used in…
This inspection in context
Questions about this 483
What did FDA find at Nantong Chanyoo Pharmatech Co., Ltd?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and materials. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
When was Nantong Chanyoo Pharmatech Co., Ltd inspected by FDA?
The inspection ran Mar 19 – Mar 22, 2019, and the Form 483 is dated March 22, 2019.
How do I get the full Form 483 for Nantong Chanyoo Pharmatech Co., Ltd?
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