FDA Gives Abbott Molecular Warning Letter

Abbott Molecular has received a warning letter from the U.S. Food and Drug Administration, citing poor manufacturing standards at its Des Plaines, Ill., plant.

Agency inspectors visited the facility in June. The results:

• Failure to maintain and implement complete procedures for acceptance or rejection of finished device production runs, lots, or batches as required by 21 CFR § 820,80(d).

• Failure to adequately control products that do not conform to specifications as required by 21 CFR § 820.90(a).

• Failure to establish and follow procedures for the identification, documentation, and validation or verification of design changes prior to the implementation of the changes as required by 21 CFR § 820.30(i).

• Failure to have completely defined procedures for implementing corrective and preventive actions as required by 21 CFR § 820.100(a).

• Failure to identify acceptance criteria for design outputs as required by 21 CFR § 820.30(d).

• Failure to completely define the corrective and preventive action procedures addressing the investigation of the cause of nonconformities relating to product, processes, and the quality system as required by 21 CFR § 820.100(a)(2).


Visit www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm189807.htm to see the complete warning letter.