Emergent Manufacturing Operations Baltimore, LLC
FDA inspection history across 2 sites, 2020 to 2021
- 2
- Form 483s
- 1
- Response
Every document, by year
- Form 483
- Response
2020: one 483 response and one Form 483; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020–21Two Form 483s and one 483 response, at Maryland and Baltimore, Maryland.
- 2021The longest 483 on file: 9 observations over 14 pages at Baltimore, Maryland.
Cited most
Across all Emergent Manufacturing Operations Baltimore observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.25Personnel qualifications2
- 21 CFR 211.160General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.194Laboratory records1
The complete Emergent Manufacturing Operations Baltimore file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Baltimore, Maryland
Two Form 483s · 2020 to 2021 · 14 observations
Latest: Form 483, Apr 20, 2021 →Maryland
One 483 response · 2020
Latest: Response, May 8, 2020 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-04-20 | 483 Form 483 | Baltimore, Maryland | 9 | $99 |
| 2020-05-08 | Response 483 response | Maryland | — | $199 |
| 2020-04-20 | 483 Form 483 | Baltimore, Maryland | 5 | $99 |
Investigators on these documents
Cody D. Rickman (1)Debra M. Emerson (1)Marcellinus D. Dordunoo (1)
FEI number 3015448605 · most recent document Apr 20, 2021
About Emergent Manufacturing Operations Baltimore, LLC
How many FDA Form 483s has Emergent Manufacturing Operations Baltimore, LLC received?
FDA Intel has 2 Form 483s on file for Emergent Manufacturing Operations Baltimore, LLC; the most recent is dated Apr 20, 2021.
When was Emergent Manufacturing Operations Baltimore, LLC last inspected by FDA?
The most recent FDA inspection document on file for Emergent Manufacturing Operations Baltimore, LLC is a Form 483 dated Apr 20, 2021, for the site in Baltimore, Maryland.
What did FDA cite at Emergent Manufacturing Operations Baltimore, LLC?
The regulations cited most in the observations on file for Emergent Manufacturing Operations Baltimore, LLC are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.25 (Personnel qualifications), 2 times; 21 CFR 211.160 (General requirements), 1 time.