Overview
- 11 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-11-27.
At a glance
Inspections
11
Form 483s
7
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Nov 2024 – 27 Nov 2024 | Biologics | 483 | View 483 → |
| 15 Feb 2022 – 23 Feb 2022 | Biologics | Clean | |
| 14 Jan 2020 – 24 Jan 2020 | Biologics | 483 | On file |
| 12 Mar 2018 – 22 Mar 2018 | Biologics | 483 | On file |
| 25 Mar 2016 – 1 Apr 2016 | Biologics | 483 | On file |
| 19 Mar 2013 – 25 Mar 2013 | Biologics | 483 | On file |
| 25 May 2011 | Not recorded | 483 | On file |
| 24 Apr 2009 | Not recorded | 483 | On file |
| 12 Apr 2007 | Not recorded | Clean | |
| 7 Jun 2002 | Not recorded | Clean | |
| 10 Feb 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Nov 2024
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Unnee Ranjan, Lizaida Perez, Brentley S Pittman
27 Nov 2024
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Unnee Ranjan, Lizaida Perez, Brentley S Pittman
27 Nov 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Unnee Ranjan, Lizaida Perez, Brentley S Pittman
27 Nov 2024
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Unnee Ranjan, Lizaida Perez, Brentley S Pittman
27 Nov 2024
21 CFR 211.63
Equipment Design, Size and Location
Cited by Unnee Ranjan, Lizaida Perez, Brentley S Pittman
Investigators
FDA investigators tied to this site in the record.
Burnell M Henry3 insp.
Unnee Ranjan1 insp.
Lizaida Perez1 insp.
Brentley S Pittman1 insp.
Claire M Minden1 insp.
Marla A Cassidy1 insp.
Mihaly S Ligmond1 insp.
Steven E Bowen1 insp.
Cynthia Jim1 insp.
Prabhu P Raju1 insp.
Jacqueline M Diaz Albert1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Merck Teknika LLC'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