The W.S. Badger Company, Inc
Form 483 issued June 1, 2023 · Gilsum, New Hampshire
- Inspection
- Apr 10 – Jun 1, 2023
- Investigators
- Daniel L. Zheng· Lori M. Newman
- Observations
- 11
- Pages
- 14
- FEI number
- 3009946959
In short: On June 1, 2023, FDA issued a Form 483 with 11 observations to The W.S. Badger Company, Inc in Gilsum, New Hampshire (FEI 3009946959) after an inspection that ran Apr 10 – Jun 1, 2023. The investigators were Daniel L. Zheng and Lori M. Newman. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 7 of 11 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 03
The batch production and control records are deficient in that they do not include documentation of…
- 04
Yom examination and testing of samples did not assure that the drug product and in-proce‘ss…
This inspection in context
Daniel L. Zheng
24 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
The firmThe W.S. Badger Company, Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at The W.S. Badger Company, Inc?
FDA listed 11 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected The W.S. Badger Company, Inc?
Daniel L. Zheng and Lori M. Newman are named on this Form 483, for the inspection of Apr 10 – Jun 1, 2023. Each investigator has a profile showing what they cite most.
When was The W.S. Badger Company, Inc inspected by FDA?
The inspection ran Apr 10 – Jun 1, 2023, and the Form 483 is dated June 1, 2023.
How do I get the full Form 483 for The W.S. Badger Company, Inc?
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