Overview
- 16 public-safe observations are available for this inspection.
- 16 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.
7 Jun 2021
21 CFR 111.35(b)(2)
Document-equipment date of use, maintain, clean, sanitize
Cited by Marcellinus D Dordunoo, Shirshendu K Deb
7 Jun 2021
21 CFR 211.100(a)
Absence of Written Procedures
Cited by Marcellinus D Dordunoo, Shirshendu K Deb
7 Jun 2021
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Marcellinus D Dordunoo, Shirshendu K Deb
7 Jun 2021
21 CFR 211.130(a)
Prevention of cross contamination, mix-ups
Cited by Marcellinus D Dordunoo, Shirshendu K Deb
7 Jun 2021
21 CFR 211.160(a)
Lab controls established, including changes
Cited by Marcellinus D Dordunoo, Shirshendu K Deb
Inspected site
BLBell-More Labs, Inc.Hampstead, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 111.35(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.165(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(v) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 16 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