Overview
- 24 public-safe observations are available for this inspection.
- 12 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
24 Aug 2021
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Liming Zhang, Cecilia H Kieu
24 Aug 2021
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Liming Zhang, Cecilia H Kieu
24 Aug 2021
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Liming Zhang, Cecilia H Kieu
24 Aug 2021
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Liming Zhang, Cecilia H Kieu
24 Aug 2021
21 CFR 211.142(b)
Storage under appropriate conditions
Cited by Liming Zhang, Cecilia H Kieu
Inspected site
BLBlaine Labs IncSanta Fe Springs, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.42(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
Source document
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Form 483 source document
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Full 483 report
Get the verbatim text of all 24 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