Overview
- 12 public-safe observations are available for this inspection.
- 12 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.
21 Dec 2018
21 CFR 211.170(b)
Reserve samples identified, representative, stored
Cited by Laurimer Kuilan-Torres, Jose E Melendez, Miguel A Martinez
21 Dec 2018
21 CFR 211.194(d)
Laboratory equipment calibration records
Cited by Laurimer Kuilan-Torres, Jose E Melendez, Miguel A Martinez
21 Dec 2018
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Laurimer Kuilan-Torres, Jose E Melendez, Miguel A Martinez
21 Dec 2018
21 CFR 211.80(a)
Procedures To Be in Writing
Cited by Laurimer Kuilan-Torres, Jose E Melendez, Miguel A Martinez
21 Dec 2018
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Laurimer Kuilan-Torres, Jose E Melendez, Miguel A Martinez
Inspected site
BHBaxter Healthcare CorporationJayuya, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(a) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 12 observations
The source PDF and 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