Overview
- 8 public-safe observations are available for this inspection.
- 8 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.
28 Mar 2011
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jose A Cruz Gonzalez, Raquel Gonzalez Rivera, Wanda J Torres
28 Mar 2011
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Jose A Cruz Gonzalez, Raquel Gonzalez Rivera, Wanda J Torres
28 Mar 2011
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Jose A Cruz Gonzalez, Raquel Gonzalez Rivera, Wanda J Torres
28 Mar 2011
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Jose A Cruz Gonzalez, Raquel Gonzalez Rivera, Wanda J Torres
28 Mar 2011
21 CFR 211.165(e)
Test methods
Cited by Jose A Cruz Gonzalez, Raquel Gonzalez Rivera, Wanda J Torres
Inspected site
BSBristol-Myers Squibb Holdings Pharma Ltd. Liability CompanyManati, 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 | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 8 observations
Every observation in full, 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