Pharmacy Courses

Most Common FDA 483 Observations


1. The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. 

2. There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its components to meet any of its specifications] whether or not the batch has been already distributed.

3. Your firm failed to establish [adequate] written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.

4. Laboratory controls do not include the establishment of scientifically sound and appropriate [specifications] [standards] [sampling plans] [test procedures] designed to assure that [components] [drug product containers] [closures] [in-process materials] [labeling] [drug products] conform to appropriate standards of identity, strength, quality and purity.

5. Equipment used in the manufacture, processing, packing or holding of drug products is not [of appropriate design] [of adequate size] [suitably located] to facilitate operations for its [intended use] [cleaning and maintenance].

6. Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

7. Equipment and utensils are not [cleaned] [maintained] [sanitized] at appropriate intervals to prevent [malfunctions] [contamination] that would alter the safety, identity, strength, quality or purity of the drug product.

8. Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the [final specifications] [identity and strength of each active ingredient] prior to release.

9. Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written] [followed].

10. Written procedures are not [established] [followed] for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

11. Routine [calibration] [inspection] [checking] of [automatic] [mechanical] [electronic] equipment is not performed according to a written program designed to assure proper performance.  

12. Employees are not given training in [the particular operations they perform as part of their function] [current good manufacturing practices] [written procedures required by current good manufacturing practice regulations].  

13. Written records of investigations into [unexplained discrepancies] [the failure of a batch or any of its components to meet specifications] do not [always] include the conclusions and follow-up.  

14. Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. 

15. There is no written testing program designed to assess the stability characteristics of drug products.

16. The [accuracy] [sensitivity] [specificity] [reproducibility] of test methods have not been [established] [documented].  

17. Written production and process control procedures are not [followed in the execution of production and process control functions] [documented at the time of performance].

18. Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.

19. Procedures describing the handling of written and oral complaints related to drug products are [not written or followed] [deficiently written or followed].

20. Deviations from written production and process control procedures are not [recorded] [justified].


Previous Post Next Post