Overview
- 10 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
27 May 2015
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Phillip M Pontikos, Rafael Padilla, MDSAP PontikosP
27 May 2015
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Phillip M Pontikos, Rafael Padilla, MDSAP PontikosP
27 May 2015
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Phillip M Pontikos, Rafael Padilla, MDSAP PontikosP
27 May 2015
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Phillip M Pontikos, Rafael Padilla, MDSAP PontikosP
27 May 2015
21 CFR 820.30(h)
Incorrect translation to production specifications
Cited by Phillip M Pontikos, Rafael Padilla, MDSAP PontikosP
Inspected site
HIHospira Inc., A Pfizer CompanyLake Forest, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 2x |
Source document
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PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 10 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere