CooperSurgical, Inc.
Form 483 issued March 4, 2022 · North Tonawanda, New York
- Inspection
- Feb 28 – Mar 4, 2022
- Observations
- 5
- Pages
- 7
- FEI number
- 1316626
In short: On March 4, 2022, FDA issued a Form 483 with 5 observations to CooperSurgical, Inc. in North Tonawanda, New York (FEI 1316626) after an inspection that ran Feb 28 – Mar 4, 2022. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
3 of 5 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 02
Written records of investigation of a drug complaint do not include the findings of the…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Questions about this 483
What did FDA find at CooperSurgical, Inc.?
FDA listed 5 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. 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 CooperSurgical, Inc. inspected by FDA?
The inspection ran Feb 28 – Mar 4, 2022, and the Form 483 is dated March 4, 2022.
How do I get the full Form 483 for CooperSurgical, Inc.?
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