FDA Inspection
Amphastar Laboratories, Inc.Amphastar Laboratories, Inc. – FDA Inspection, Oct 21, 2016
Record Details
This FDA Inspection record concerns Amphastar Laboratories, Inc., with an inspection on October 21, 2016, issued by the Los Angeles District Office, covering human drugs.
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ID · eb90ebd2-284e-4f75-8248-8873ce77f31c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 992717
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 58.120(a)Protocol: approved
- 21 CFR 58.120(b)Protocol: approval of changes
- 21 CFR 58.185(a)(10)Final report: names of those involved
- 21 CFR 58.29(b)Personnel: summary of training, job description
- 21 CFR 58.33(a)Study director: follow study protocol
- 21 CFR 58.33(b)Study director: all data recorded and verified
- 21 CFR 58.33(f)Study director: transfer of data to archives
- 21 CFR 58.35(a)QAU: separate and independent
- 21 CFR 58.35(b)(3)QAU: inspect study at adequate intervals
- 21 CFR 58.51Facility: archives
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