Overview
- 18 FDA inspections are on record.
- 13 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-11-08.
At a glance
Inspections
18
Form 483s
13
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 31 Oct 2022 – 8 Nov 2022 | Human Drugs | 483 | View 483 → |
| 6 Sep 2022 – 14 Sep 2022 | Human Drugs | 483 | On file |
| 6 Jun 2022 – 17 Jun 2022 | Human Drugs | 483 | On file |
| 14 Jun 2021 – 18 Jun 2021 | Human Drugs | 483 | On file |
| 27 Jan 2020 – 6 Feb 2020 | Human Drugs | 483 | On file |
| 14 Jan 2019 – 5 Feb 2019 | Human Drugs | 483 | View 483 → |
| 12 Mar 2018 – 16 Mar 2018 | Human Drugs | 483 | On file |
| 23 Oct 2017 – 27 Oct 2017 | Human Drugs | Clean | |
| 29 Feb 2016 – 4 Mar 2016 | Human Drugs | 483 | On file |
| 17 Feb 2015 – 26 Feb 2015 | Human Drugs | 483 | View 483 → |
| 13 Nov 2013 – 19 Nov 2013 | Human Drugs | Clean | |
| 25 Mar 2013 – 28 Mar 2013 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Nov 2022
21 CFR 211.113(a)
Procedures for non-sterile drug products
Cited by Robert J Ham, Jill J Tillman, Monica E Murie
8 Nov 2022
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Robert J Ham, Jill J Tillman, Monica E Murie
8 Nov 2022
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Robert J Ham, Jill J Tillman, Monica E Murie
Investigators
FDA investigators tied to this site in the record.
Robert J Ham4 insp.
Matthew M Schuckmann4 insp.
Karen M Montgomery3 insp.
Jill J Tillman1 insp.
Monica E Murie1 insp.
Michael C Zubelewicz1 insp.
Logan T Williams1 insp.
Derrionna M Epps1 insp.
Vikas Moolchandani1 insp.
Sri Rama Kr Yellela1 insp.
Victoria P Quadrini1 insp.
Michele Perry-Williams1 insp.
Bei Y He1 insp.
Srinivas Chennamaneni1 insp.
Veronica Fuentes1 insp.
Xiaohan Cai1 insp.
Yiyue Zhang1 insp.
Dustin K Hampton1 insp.
Linda F Murphy1 insp.
Michele L Obert1 insp.
Eric M Padgett1 insp.
Tara L Greene1 insp.
Eric C Nielsen1 insp.
Michele Perry Williams1 insp.
Tara L Breckenridge1 insp.
David J Eide1 insp.
Cynthia M Goudeau1 insp.
State Agency1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(b)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(e)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(b)(9) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.48(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind S and B Pharma, Inc dba Alkem Laboratories' 13 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat