FDA Inspection
BPS 60BPS 60 – FDA Inspection, Sep 15, 2017
Record Details
This FDA Inspection record concerns BPS 60, with an inspection on September 15, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 461eece0-dbdc-4de9-8630-067a76e91572
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1027348
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.82(b)Quarantine Storage of Components
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.42(c)(1)Incoming material area
- 21 CFR 211.122(a)Written procedures describing in detail
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