483
Macleods Pharmaceuticals LimitedMacleods Pharmaceuticals Limited – FDA 483, Oct 20, 2023
Record Details
Macleods Pharmaceuticals Limited, a non-sterile drug manufacturer in Baddi, India, was cited for multiple significant deficiencies during an FDA inspection. Repeat observations included inadequate cleaning procedures and insufficient computer system controls. The firm also failed to ensure proper stability testing, quality control review of records, and timely Field Alert Report submission, indicating a broad range of quality system issues.
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ID · 24719885-17b2-4812-8dbf-1a797866f892
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