FDA 483 Observations FY 2024

Top 10 FDA 483 Observations – FY 2024

1. Procedures Not Established or Followed (21 CFR 211.100(a))
   Failure to establish and follow written procedures for production and process control to assure drug products have the identity, strength, quality, and purity they purport or are represented to possess.
2. Laboratory Controls Not Scientifically Sound (21 CFR 211.160(b))
   Laboratory controls did not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures.
3. Lack of Written Procedures for Deviations (21 CFR 211.100(b))
   Written production and process control procedures were not followed, and deviations from written procedures were not recorded and justified.
4. Failure to Investigate Discrepancies (21 CFR 211.192)
   Laboratory records did not include complete data derived from all tests necessary to assure compliance with established specifications and standards.
5. Inadequate Cleaning and Maintenance of Equipment (21 CFR 211.67(b))
   Equipment and utensils were not cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product.
6. Inadequate Control of Components and Drug Product Containers (21 CFR 211.84(d))
   Components, drug product containers, and closures were not tested or examined before use in production to assure that they met all appropriate written specifications.
7. Failure to Establish Adequate Written Procedures for Production and Process Control (21 CFR 211.100(a))
   Written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess were not established.
8. Inadequate Personnel Training (21 CFR 211.25(a))
   Employees engaged in the manufacture, processing, packing, or holding of a drug product did not have the education, training, and experience to perform their assigned functions.
9. Lack of Control Procedures to Monitor and Validate Performance (21 CFR 211.110(a))
   Control procedures were not established to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
10. Inadequate Documentation of Production and Process Control (21 CFR 211.100(b))
    Deviations from written production and process control procedures were not recorded and justified.

These observations highlight persistent challenges in areas such as process validation, laboratory controls, equipment maintenance, and personnel training. Addressing these issues requires a comprehensive review of quality systems and a commitment to continuous improvement.

For detailed information and to access the full dataset of FDA inspectional observations for FY 2024, please refer to the FDA’s official resource:

 FDA Inspection Observations

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