ABBE Laboratories, Inc.
6 extracted findings · 5 model-assigned issue types
FDA source excerpt, selected passage
Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Failed to test identity of each component shipment and validate supplier test analyses.
Supporting FDA text
Source excerpt · automated text-match checkYour firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).
Failed to perform identity testing for high-risk components like propylene glycol and glycerin.
Supporting FDA text
Source excerpt · automated text-match checkYou also failed to adequately test for identity each shipment of every lot of propylene glycol and glycerin, components at higher risk of diethylene glycol (DEG) or ethylene glycol (EG) contamination, received at your facility.
Cleaning validation study was inadequate and lacked worst-case product determination.
Supporting FDA text
Source excerpt · automated text-match checkYour 2009 cleaning validation study for the Kettle (b)(4) equipment is inadequate to ensure your cleaning procedures are effective for the multiple OTC drug products your firm manufactures.
Failed to perform new cleaning validation when introducing a new product.
Supporting FDA text
Source excerpt · automated text-match checkYou also failed to perform a new cleaning validation study when you began manufacturing a new drug product, End Zit Acne Drying Lotion, which you determined to be the most difficult to clean product due to the titanium dioxide active ingredient, on shared equipment.
Cleaning validation study lacked analysis for API residues.
Supporting FDA text
Source excerpt · automated text-match checkIn addition, the cleaning validation study for your kettle lacked analysis for API residues.
Stopped documenting cleaning activities in logbooks around 2020.
Supporting FDA text
Source excerpt · automated text-match checkyou stopped documenting cleaning activities in your logbooks and status of the equipment around 2020.
Failed to provide validation protocols and reports for manufacturing processes.
Supporting FDA text
Source excerpt · automated text-match checkyou were unable to provide a validation protocol and corresponding report with established parameters (e.g., mixing speeds, temperature, hold times prior to filling) to demonstrate process control for each product you manufacture.
Process validation finding is a repeat from 2018 inspection.
Supporting FDA text
Source excerpt · automated text-match checkThis is a repeat finding from your 2018 inspection when you committed to initiate process validation by September 2018 and forward final reports to FDA upon completion.
Quality unit lacked oversight and released products with incomplete records.
Supporting FDA text
Source excerpt · automated text-match checkwe collected documents, including batch records and an out-of-specification investigation record, that were incomplete (e.g., documents had blank spaces, missing signatures), although the OTC drug products were released by your quality unit (QU).
Failed to perform annual product reviews since at least 2018.
Supporting FDA text
Source excerpt · automated text-match checkyou failed to perform annual product reviews of your OTC drug products since at least 2018.
Failed to complete final release checklist for distributed batches.
Supporting FDA text
Source excerpt · automated text-match checkyou failed to complete the Finished Product Final Release Checklist for at least (b)(4) batches of OTC drug products already distributed to the market.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
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What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Provide DEG and EG test results from retains for all high-risk component lots.
- Perform retain testing of finished batches if component retains unavailable.
- Provide full risk assessment for products containing DEG/EG risk ingredients.
- Describe testing of each component lot for identity, strength, quality, purity.
- Provide chemical quality control specifications for high-risk components.
- Provide independent review of material system and supplier qualifications.
- Provide CAPA plan for cleaning and disinfection program remediation.
- Provide comprehensive assessment and remediation plan for quality unit.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.