Foshan Biours Biosciences Co., Ltd.
3 extracted findings · 3 model-assigned issue types
FDA source excerpt, selected passage
you submitted a certificate of analysis for your OTC (b)(4) Patch that shows you did not conduct adequate testing for identity and strength of the active ingredient, (b)(4), as is required prior to release per 211.165(a)
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Release testing was inadequate because the certificate of analysis lacked identity and strength testing for the active ingredient.
Supporting FDA text
Source excerpt · automated text-match checkyou submitted a certificate of analysis for your OTC (b)(4) Patch that shows you did not conduct adequate testing for identity and strength of the active ingredient, (b)(4), as is required prior to release per 211.165(a)
There were no validated cleaning procedures for non-dedicated equipment used to manufacture and package the product.
Supporting FDA text
Source excerpt · automated text-match checkyou indicated that there was no validated cleaning procedure for the equipment used in the manufacture and packaging of your OTC (b)(4) Patch
Stability data did not include testing for the active ingredient, failing to demonstrate the drug is stable throughout shelf life.
Supporting FDA text
Source excerpt · automated text-match checkyour stability data for OTC (b)(4) Patch does not include testing for the active ingredient
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
Source passage selected by the model
Source passage selected by the model
What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- A list of chemical and microbial specifications including test methods used to analyze each lot
- An action plan and timelines for conducting full chemical and microbiological testing of retain samples
- A summary of all results obtained from testing retain samples from each batch
- Rapid corrective actions if testing reveals substandard quality
- A comprehensive independent assessment of laboratory practices procedures methods equipment documentation analyst competencies
- Detailed plan to remediate laboratory system
- Steps to develop an adequate cleaning validation program with identification and evaluation of worst-case drugs
- A summary of updated SOPs for verification and validation of cleaning procedures for products processes and equipment
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.