FDA Inspection
The Female Health Company (M) Sdn BhdThe Female Health Company (M) Sdn Bhd – FDA Inspection, Sep 3, 2010
Record Details
This FDA Inspection record concerns The Female Health Company (M) Sdn Bhd, with an inspection on September 3, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 3, 2010
- Product Type
- Devices
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ID · f07dd30e-9829-4955-9ffa-5bd2c334b85d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 684742
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(b)(2)Documentation of validated process performance
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