Fresh Farms LLC
6 extracted findings · 4 model-assigned issue types
FDA source excerpt, selected passage
Your firm failed to establish an adequate quality unit with responsibilities to ensure adequate oversight for the manufacture of your OTC drug products. For example, you failed to ensure that the responsibilities of the quality unit are in writing and fully followed, that your products specifications are established…
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Firm failed to establish an adequate quality unit and to ensure responsibilities were in writing and fully followed; batch release was not adequately documented.
Supporting FDA text
Source excerpt · automated text-match checkYour firm failed to establish an adequate quality unit with responsibilities to ensure adequate oversight for the manufacture of your OTC drug products. For example, you failed to ensure that the responsibilities of the quality unit are in writing and fully followed, that your products specifications are established and approved, and that the final review of each batch and its related information are adequately documented and completed before release and distribution.
Incoming components, including ethanol (API), were not tested prior to use.
Supporting FDA text
Source excerpt · automated text-match checkYou failed to sample, test, and examine components used in the manufacture of your OTC drugs including ethanol which is used as an active pharmaceutical ingredient (API) in the manufacture of (b)(4) Hand Sanitizer drug product. During the inspection, you stated that you did not test your incoming raw materials prior to use.
Release testing for identity and strength of active ingredients was not performed on any batches.
Supporting FDA text
Source excerpt · automated text-match checkYou failed to perform release testing for batches of (b)(4) Hand Sanitizer labeled as containing ethanol. During the inspection, you stated that no release testing was performed on your drug products.
No executed batch records were prepared for any drug product batches.
Supporting FDA text
Source excerpt · automated text-match checkYou lacked executed batch records for batches of (b)(4) Hand Sanitizer drug product you manufactured. During the inspection, you stated that no batch records were prepared.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
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What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Specify what you have done to address any violations and to prevent their recurrence.
- If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.