Drugs

14 Observations on Spectrum FDA-483

FDA has released the form FDA-483 issued following a 2/8-3/24 inspection at Spectrum Laboratory Products, a New Brunswick, NJ, repacker/relabeler. The FDA-483 contains these 14 inspection observations:

failing to conduct repackaging operations under appropriate environmental conditions to avoid contamination and cross-contamination;
failing to validate cleaning procedures;
failing to have defined areas or other control systems for activities within the warehouse;
failing to establish and follow written procedures for investigating critical deviations or the failure of a batch of active pharmaceutical ingredient (API) to meet specifications, and investigations do not extend to other batches that may have been associated with the specific failure or deviations;
failing to verify and document the suitability of all test methods under actual conditions;
failing to have laboratory controls include complete data derived from all tests conducted to ensure compliance with established specifications and standards, including examinations and assays;
all specifications, sampling plans, and test procedures are not scientifically sound and appropriate to ensure that raw materials, intermediates, APIs, and labeling and packaging materials conform to established standards of quality and/or purity;
failing to conduct stability studies to justify assigned expiration or retest dates of repackaged API products in different types of containers/closures than that used by the API manufacturer;
failing to ensure that all critical deviations are investigated and resolved;
failing to conduct complaint investigations to determine the cause;
the Quality Unit does not review and approve all appropriate quality-related documents;
failing to have master production records include detailed production instructions;
failing to have batch production and control records dated and signed when issued; and
failing to have an adequate number of personnel qualified by appropriate training to perform and supervise the manufacture of APIs.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome