FDA Inspection
Palamur Biosciences Private LimitedPalamur Biosciences Private Limited – FDA Inspection, Jan 27, 2025
Record Details
This FDA Inspection record concerns Palamur Biosciences Private Limited, with an inspection on January 27, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- January 27, 2025
- Product Type
- Medical Devices & Rad Health
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ID · f3e1ab86-2470-4aed-9718-fd18ba40d8e7
Inspection Facts
- Inspection number
- 1259529
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring: Human Drugs
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 58.113(a)(1)Mixtures: uniformity and concentration
- 21 CFR 58.130(c)Conduct: identification of test specimens
- 21 CFR 58.31(f)Management: personnel understand their functions
- 21 CFR 58.33(b)Study director: all data recorded and verified
- 21 CFR 58.35(b)(1)QAU: maintain a master schedule
- 21 CFR 58.35(b)(3)QAU: inspect study at adequate intervals
- 21 CFR 58.35(b)(5)QAU: authorize deviations from protocols or SOPs
- 21 CFR 58.35(b)(6)QAU: review final study report
- 21 CFR 58.81(a)SOPs: laboratory methods
- 21 CFR 58.90(f)Animal care: cage and equipment cleaning
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