FDA Inspection
MICROTROL STERILISATION SERVICES PRIVATE LIMITEDMICROTROL STERILISATION SERVICES PRIVATE LIMITED – FDA Inspection, Dec 19, 2023
Record Details
This FDA Inspection record concerns MICROTROL STERILISATION SERVICES PRIVATE LIMITED, with an inspection on December 19, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 19, 2023
- Product Type
- Drugs
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ID · c0ea105d-4bc8-482e-9791-2526ee1343bd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1225972
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.63Equipment Design, Size and Location
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