The W.S. Badger Company, Inc
Form 483 issued September 14, 2021 · GILSUM, New Hampshire
- Inspection
- Aug 30 – Sep 14, 2021
- Observations
- 7
- Pages
- 6
- FEI number
- 3009946959
In short: On September 14, 2021, FDA issued a Form 483 with 7 observations to The W.S. Badger Company, Inc in GILSUM, New Hampshire (FEI 3009946959) after an inspection that ran Aug 30 – Sep 14, 2021. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 5 of 7 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
The establishment of test procedures and laboratory control mechanisms including any changes thereto, are not reviewed…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
This inspection in context
Questions about this 483
What did FDA find at The W.S. Badger Company, Inc?
FDA listed 7 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was The W.S. Badger Company, Inc inspected by FDA?
The inspection ran Aug 30 – Sep 14, 2021, and the Form 483 is dated September 14, 2021.
How do I get the full Form 483 for The W.S. Badger Company, Inc?
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.