Next Medical Products Company, LLC
1 extracted findings
FDA source excerpt, selected passage
Failure to establish and maintain procedures where environmental conditions that could reasonably be expected to have an adverse effect on product quality, as required by 21 CFR 820.70(c). Specifically, “Quality Assurance Environmental Testing” procedure, Number 907-030, Revision 005 is not adequate in that:
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Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
Failure to establish and maintain procedures where environmental conditions that could reasonably be expected to have an adverse effect on product quality, as required by 21 CFR 820.70(c). Specifically, “Quality Assurance Environmental Testing” procedure, Number 907-030, Revision 005 is not adequate in that:
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.