Gadal Laboratories Inc.
4 extracted findings · 4 model-assigned issue types
FDA source excerpt, selected passage
Your firm failed to qualify your suppliers and adequately test the components used to manufacture your finished drug products, including pediatric over-the-counter (OTC) (b)(4) products.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Failed to qualify suppliers and adequately test components, including active ingredients and excipients.
Supporting FDA text
Source excerpt · automated text-match checkYour firm failed to qualify your suppliers and adequately test the components used to manufacture your finished drug products, including pediatric over-the-counter (OTC) (b)(4) products.
Approved an active ingredient from an unqualified supplier without establishing COA reliability.
Supporting FDA text
Source excerpt · automated text-match check(b)(4), one of your active ingredients is sourced from an unqualified supplier and was approved for use without establishing the reliability of your suppliers’ certificate of analysis (COA).
Microbiological testing for an excipient lacked specificity on objectionable organisms.
Supporting FDA text
Source excerpt · automated text-match checkThe microbiological testing of (b)(4) excipient in your supplier qualification document only included a general statement that it should be free from pathogens but lacked any further specificity on microorganisms that your firm considers to be objectionable.
Lacked specific identity tests for high-risk components before use in manufacturing.
Supporting FDA text
Source excerpt · automated text-match checkYou lacked a specific identity test to detect (b)(4) and (b)(4) in all shipments, containers, and lots of (b)(4) and (b)(4) before use in the manufacturing of drug products.
Failed to adequately validate production and process controls for OTC drug products.
Supporting FDA text
Source excerpt · automated text-match checkYou failed to adequately validate your production and process controls. You did not have assurance that you are capable of consistently manufacturing OTC drug products with defined quality attributes.
Failed to adequately qualify and test the water system for chemical and microbiological standards.
Supporting FDA text
Source excerpt · automated text-match checkYou also failed to adequately qualify and test your (b)(4) system to assure the (b)(4) produced from the system consistently meets chemical and microbiological standards and is suitable for use as a raw material in drug manufacturing or for cleaning.
Failed to thoroughly validate cleaning processes and verification program.
Supporting FDA text
Source excerpt · automated text-match checkYou have not thoroughly validated your cleaning processes and your cleaning verification program does not adequately detect potential cross-contamination between products or microbiological contamination.
Replaced inactive ingredients without documented rationale or stability studies.
Supporting FDA text
Source excerpt · automated text-match checkYou replaced the inactive ingredient with another inactive ingredient, without documented scientific rationale and justification, in multiple batches of your OTC drug products.
Laboratory data recorded on uncontrolled sheets, in pencil, and altered with correction fluid.
Supporting FDA text
Source excerpt · automated text-match checkAnalysts documented original laboratory data on uncontrolled sheets of paper. Analysts also recorded raw data in pencil and changed written data using correction fluid to obscure the original result.
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
Source passage selected by the model
What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Comprehensive independent review of material system and supplier qualifications
- Remaining DEG/EG test results for finished products and retains within 30 days
- Full risk assessment for products within expiry containing DEG/EG-risk ingredients
- Risk assessment of components released without appropriate purity, strength, quality testing
- Review of microbial effectiveness testing for multi-use non-sterile products with CAPA
- Chemical and microbiological specifications for each incoming component lot
- Description of component lot testing and COA validation program with SOP
- Summary of COA reliability testing results and SOP
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.