Overview
- 7 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-27.
At a glance
Inspections
7
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Sep 2024 – 27 Sep 2024 | Human Drugs | 483 | On file |
| 10 Jul 2023 – 20 Jul 2023 | Human Drugs | 483 | On file |
| 22 Aug 2022 – 30 Aug 2022 | Human Drugs | 483 | On file |
| 13 Sep 2021 – 24 Sep 2021 | Human Drugs | 483 | On file |
| 10 Feb 2020 – 21 Feb 2020 | Human Drugs | 483 | View 483 → |
| 24 Jun 2019 – 5 Jul 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 6 Feb 2018 – 15 Feb 2018 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Feb 2020
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Shawn E Larson, Vidya B Pai
21 Feb 2020
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Shawn E Larson, Vidya B Pai
21 Feb 2020
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Shawn E Larson, Vidya B Pai
5 Jul 2019
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Linda F Murphy, Maryam Tabatabaie, Katherine D Adams
5 Jul 2019
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Linda F Murphy, Maryam Tabatabaie, Katherine D Adams
Investigators
FDA investigators tied to this site in the record.
Jeffrey P Raimondi1 insp.
Sandra A Boyd1 insp.
Daniel J Lahar1 insp.
Patty P Kaewussdangkul1 insp.
Eileen A Liu1 insp.
Rong Guo1 insp.
Santos E Camara1 insp.
Richard Ledwidge1 insp.
Hamet M Toure1 insp.
Wayne E Seifert1 insp.
Shawn E Larson1 insp.
Vidya B Pai1 insp.
Linda F Murphy1 insp.
Maryam Tabatabaie1 insp.
Katherine D Adams1 insp.
Roger F Zabinski1 insp.
Jose E Melendez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.42(c)(10)(iv) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 3x |
Full site report
Get the verbatim findings behind BIOCON SDN.BHD.'s 7 Form 483s
Source PDFs 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